1402 Final Protocol - Department of Health
MEDICAL SERVICES ADVISORY COMMITTEEFinal protocol to guide the assessment of microwave tissue ablation for primary and secondary liver cancerMSAC Application 1402January 2016Table of Contents TOC \o "1-3" \h \z \u 1Title of application PAGEREF _Toc429378655 \h 12Purpose of application PAGEREF _Toc429378656 \h 13Intervention – proposed medical service PAGEREF _Toc429378657 \h 13.1Description of the proposed medical service PAGEREF _Toc429378658 \h 13.2Registered trademark PAGEREF _Toc429378659 \h 23.3Proposed clinical setting PAGEREF _Toc429378660 \h 33.4Service delivery PAGEREF _Toc429378661 \h 34Co-dependent information PAGEREF _Toc429378662 \h 44.1Service PAGEREF _Toc429378663 \h 44.2Pharmaceutical PAGEREF _Toc429378664 \h 44.3Medical device or prosthesis PAGEREF _Toc429378665 \h 45Population eligible for the proposed medical service PAGEREF _Toc429378666 \h 45.1Medical condition relevant to the service PAGEREF _Toc429378667 \h 45.1.1Primary liver cancer PAGEREF _Toc429378668 \h 45.1.2Secondary liver cancer PAGEREF _Toc429378669 \h 55.2Proposed patient population and expected utilisation PAGEREF _Toc429378670 \h 65.3Evidence for the population that would benefit from this service PAGEREF _Toc429378671 \h 86Comparator PAGEREF _Toc429378672 \h 166.1Comparator for population 1 PAGEREF _Toc429378673 \h 166.2Comparator for population 2 PAGEREF _Toc429378674 \h 176.3Comparator for population 3 PAGEREF _Toc429378675 \h 177Clinical management algorithm PAGEREF _Toc429378676 \h 187.1Current clinical practice – Population 1 PAGEREF _Toc429378677 \h 187.2Proposed clinical practice – Population 1 PAGEREF _Toc429378678 \h 197.3Current clinical practice – Population 2 PAGEREF _Toc429378679 \h 207.4Proposed clinical practice – Population 2 PAGEREF _Toc429378680 \h 217.5Current clinical practice – Population 3 PAGEREF _Toc429378681 \h 227.6Proposed clinical practice – Population 3 PAGEREF _Toc429378682 \h 238Expected health outcomes PAGEREF _Toc429378683 \h 258.1Expected patient-relevant health outcomes PAGEREF _Toc429378684 \h 258.2Potential risks to patients PAGEREF _Toc429378685 \h 259Clinical claim for the proposed intervention PAGEREF _Toc429378686 \h 269.1Clinical claim PAGEREF _Toc429378687 \h 269.2Economic evaluation PAGEREF _Toc429378688 \h 2610Decision analytic PAGEREF _Toc429378689 \h 2711Fee for the proposed medical service PAGEREF _Toc429378690 \h 2811.1Type of funding proposed for this service PAGEREF _Toc429378691 \h 2811.2Direct costs associated with the proposed service PAGEREF _Toc429378692 \h 3011.3Proposed fee PAGEREF _Toc429378693 \h 3012Regulatory information PAGEREF _Toc429378694 \h 3113Healthcare resources PAGEREF _Toc429378695 \h 3314Questions for public funding PAGEREF _Toc429378696 \h 3315References PAGEREF _Toc429378697 \h 3916Appendix A: potentially relevant literature PAGEREF _Toc429378698 \h 4316.1Comparative studies PAGEREF _Toc429378699 \h 4316.2Single arm studies PAGEREF _Toc429378700 \h 46List of TermsBCLCBarcelona Clinic Liver CancerCPGclinical practice guidelineCRCcolorectal cancerCECTcontrast enhanced computed tomographyCTcomputed tomographyGHzGigaHertzHCChepatocellular carcinomaHIFUhigh-intensity focused ultrasoundLAPSLigation for Staged HepatectomyLTPlocal tumour progressionMBSMedicare Benefits ScheduleMHzMegaHertZMTAmicrowave tissue ablationMSACmedical services advisory committeeMWAmicrowave ablationNAnot applicableNRnot reportedPEIpercutaneous ethanol injectionPETPositron emission tomographyPET-MRIPositron emission tomography–magnetic resonance imagingRANZCRRoyal College of Australian and New Zealand RadiologistRCTrandomised controlled trialRFAradiofrequency ablationUSultrasoundUSAUnited States of AmericaWwattsTitle of applicationMicrowave Tissue Ablation (MTA) for primary and secondary liver cancerPurpose of applicationMTA uses radiation in the electromagnetic spectrum to produce cell death via coagulative necrosis radial to a needle inserted into a liver tumour. MTA can be used to provide potentially curative tumour ablation to a proportion of patients with primary liver lesions or with liver metastases from extra-hepatic primary cancers who are not considered to be candidates for surgical resection. Resection of a tumour may be contraindicated due to tumour location or extent, poor physiological hepatic reserve due to diffuse liver disease, and the presence of prohibitive co-morbidities PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CaGFyZHdhajwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+
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ADDIN EN.CITE.DATA (Bhardwaj et al. 2010; Swan et al. 2012).A multi-modality treatment approach may also be undertaken for patients with primary liver tumours or metastases in the liver, using MTA in conjunction with liver resection, chemoembolisation, radiotherapy or other regional or systemic cancer treatments ADDIN EN.CITE <EndNote><Cite><Author>Swan</Author><Year>2012</Year><RecNum>34</RecNum><DisplayText>(Swan et al. 2012)</DisplayText><record><rec-number>34</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432260904">34</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Swan, R. Z.</author><author>Tsirline, V.</author><author>Sindram, D.</author><author>Martinie, J. B.</author><author>Iannitti, D. A.</author></authors></contributors><titles><title>Fundamentals of microwave physics: application to hepatic ablation</title><secondary-title>J Microwave Surg</secondary-title></titles><periodical><full-title>J Microwave Surg</full-title></periodical><volume>30</volume><dates><year>2012</year></dates><urls></urls></record></Cite></EndNote>(Swan et al. 2012). Current clinical treatment for these patients is radiofrequency ablation (RFA). For patients with unresectable HCC MBS items 50950 and 50952 can be claimed for RFA procedures. The applicant claims that MTA offers faster and more predictable tumour ablation zones, which reach higher temperatures during ablation and are less susceptible to the heat sink effect. It is also claimed that there is a lower risk of tumour recurrences compared to RFA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CaGFyZHdhajwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+
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ADDIN EN.CITE.DATA (Bhardwaj et al. 2010). The applicant has advised that MTA is currently used in both the public and private settings; however, as there is no current Medicare Benefits Schedule (MBS) service for MTA, patients in the private setting must meet the full cost of treatment. There are four microwave ablation devices registered on the Australian register of therapeutic goods (ARTG) which are used in Australia for ablation of the liver and other soft tissue organs.There are 11 systematic reviews that provide background on MTA. The most recent is Loveman et al. PEVuZE5vdGU+PENpdGUgRXhjbHVkZUF1dGg9IjEiPjxBdXRob3I+TG92ZW1hbjwvQXV0aG9yPjxZ
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ADDIN EN.CITE.DATA (2014) on the use of MTA to treat liver metastases, which includes an economic assessment. A thorough description of MTA treatment of unresectable HCC and CRC in a worldwide context is given in Boutros et al. ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1"><Author>Boutros</Author><Year>2010</Year><RecNum>27</RecNum><DisplayText>(2010)</DisplayText><record><rec-number>27</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1431496861">27</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Boutros, C.</author><author>Somasundar, P.</author><author>Garrean, S.</author><author>Saied, A.</author><author>Espat, N. J.</author></authors></contributors><auth-address>Hepatobiliary and Surgical Oncology, Roger Williams Medical Center, 825 Chalkstone Ave., Providence, RI 02908, USA.</auth-address><titles><title>Microwave coagulation therapy for hepatic tumors: review of the literature and critical analysis</title><secondary-title>Surg Oncol</secondary-title><alt-title>Surgical oncology</alt-title></titles><periodical><full-title>Surg Oncol</full-title><abbr-1>Surgical oncology</abbr-1></periodical><alt-periodical><full-title>Surg Oncol</full-title><abbr-1>Surgical oncology</abbr-1></alt-periodical><pages>e22-32</pages><volume>19</volume><number>1</number><edition>2009/03/10</edition><keywords><keyword>Carcinoma, Hepatocellular/secondary/*surgery</keyword><keyword>Catheter Ablation</keyword><keyword>Cautery/instrumentation/*methods</keyword><keyword>Colorectal Neoplasms/*pathology</keyword><keyword>Humans</keyword><keyword>Liver Neoplasms/secondary/*surgery</keyword><keyword>Microwaves/*therapeutic use</keyword></keywords><dates><year>2010</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>0960-7404</isbn><accession-num>19268571</accession-num><urls></urls><electronic-resource-num>10.1016/j.suronc.2009.02.001</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(2010). Liang et al. PEVuZE5vdGU+PENpdGUgRXhjbHVkZUF1dGg9IjEiPjxBdXRob3I+TGlhbmc8L0F1dGhvcj48WWVh
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ZT4A
ADDIN EN.CITE.DATA (2013) summarizes the first clinical practice guideline for ultrasound-guided percutaneous MTA from the Society of Chinese Interventional Ultrasound.MTA for liver tumours has not previously been considered by MSAC. Intervention – proposed medical serviceDescription of the proposed medical serviceMicrowaves are the part of the electromagnetic spectrum with frequencies ranging from 900 to 2450MHz. Microwave wavelengths lie between those of infrared radiation and radio waves ADDIN EN.CITE <EndNote><Cite><Author>Banik</Author><Year>2003</Year><RecNum>1</RecNum><DisplayText>(Banik et al. 2003)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1430894407">1</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Banik, S.</author><author>Bandyopadhyay, S.</author><author>Ganguly, S.</author></authors></contributors><titles><title>Bioeffects of microwave––a brief review</title><secondary-title>Bioresource Technology</secondary-title></titles><periodical><full-title>Bioresource Technology</full-title></periodical><pages>155-159</pages><volume>87</volume><number>2</number><keywords><keyword>Microwave</keyword><keyword>Bioeffects</keyword><keyword>Athermal effect</keyword><keyword>Genetic mutation</keyword><keyword>Biotechnology</keyword></keywords><dates><year>2003</year><pub-dates><date>4//</date></pub-dates></dates><isbn>0960-8524</isbn><urls><related-urls><url>(02)00169-4</electronic-resource-num></record></Cite></EndNote>(Banik et al. 2003). When microwave radiation hits water molecules in tissue, they oscillate between 2–5 billion times per second, generating heat from the friction and subsequently leading to cell death through coagulative necrosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Pbmc8L0F1dGhvcj48WWVhcj4yMDA5PC9ZZWFyPjxSZWNO
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ADDIN EN.CITE.DATA (Ong et al. 2009). These antennas are straight applicators with active tips ranging in length from 0.6 to 4.0 cm, they can be single, dual or triple antennae which are simultaneously activated, and have either a straight or looped configuration affecting ablation volume PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NZXJlZGl0aDwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+
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AG==
ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NZXJlZGl0aDwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+
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AG==
ADDIN EN.CITE.DATA (Meredith et al. 2005; Yu et al. 2006). A microwave generator emits electromagnetic waves at a frequency of 2450MHz with powers ranging from 60 to 80W through the non-insulated portion of the antenna to surrounding tissue PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb25nPC9BdXRob3I+PFllYXI+MjAwMzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (Dong et al. 2003; Seki et al. 2000). Lower frequency microwave radiation at 915MHz can theoretically be applied at a power of 45W, requiring longer duration of ablation PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaW1vbjwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+PFJl
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaW1vbjwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (Simon et al. 2005; Yu et al. 2006); however use of a higher frequency microwave results in a more uniform shape and size of ablation volume. The applicant has advised that 2450MHz ablation systems are used in almost every hospital in Australia. The microwave field allows for direct and uniform deposition of energy into tissue several centimetres from the antenna, rather than relying upon current flow and resistive heating. Multiple pulses can be applied and tumours in this field are heated to over 60°C to achieve coagulative necrosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Td2FuPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (Kuang et al. 2007). The applicant has advised that follow-up cross-sectional imaging is performed approximately six weeks post-MTA. Expert advice is that follow-up imaging may be performed as early as three weeks following the MTA procedure. Registered trademarkThe application for the proposed items does not limit use to any registered trademark.There are four MTA systems available in Australia including:The Acculis system, including a device and an applicator, is registered to be used in Australia with N Stenning and Co Pty Ltd as the sponsor and uses a frequency of 2450MHz and a power of 140W. Avecure Microwave Ablation/Coagulation System - microwave hyperthermia system, sponsored by Aurora BioScience Pty Ltd. For tumours in bone, kidney, liver, lung and pancreas. This device uses 902-928MHz and 32W.Emprint? Ablation System with Thermosphere? Technology - microwave hyperthermia system (226598), an intracorporeal microwave hyperthermia applicator (178369), and two hyperthermia microwave systems (152044; 178699) sponsored by Covidien Pty Ltd. For non-resectable liver tumours. This device uses 1400-1500MHz and 100W.Amica microwave hyperthermia system (212509), and an intracorporeal microwave hyperthermia applicator (212510) sponsored by Culpan Medical Pty Ltd. For soft tissue pathologies such as solid tumours or hyperplasia of the liver, kidney, lung, bone, breast, prostate, etc. This device uses 2450MHz and 20-140W.Proposed clinical settingThe applicant has advised that both percutaneous and intra-operative MTA are conducted as in-patient procedures in both private and public hospitals within Australia. MTA usually requires an overnight stay. Percutaneous MTA is delivered in radiology departments by an interventional radiologist. Intra-operative MTA is performed in conjunction with liver surgery by the surgeon or an interventional radiologist in the operating theatre. Expert advice is that MTA is usually provided in tertiary hospitals and is highly unlikely to be performed in regional centres; however, PASC noted the applicant’s advice that if Medicare funding were approved, there may be some extension of services in the private sector.Service deliveryThe applicant has advised that patients with primary and secondary liver tumours are all reviewed at a multidisciplinary liver meeting consisting of hepatologists, gastroenterologists, hepatobiliary surgeons, medical and radiation oncologists, interventional radiologists, nursing co-ordinators, and the clinical care team. At this meeting, decisions regarding patient management are discussed. The decision to perform MTA is a consensus based on the condition of the patient, the disease status and generally on international guidelines ADDIN EN.CITE <EndNote><Cite><Author>Llovet</Author><Year>2004</Year><RecNum>127</RecNum><DisplayText>(Llovet et al. 2004)</DisplayText><record><rec-number>127</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432794823">127</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Llovet, Josep M</author><author>Fuster, Josep</author><author>Bruix, Jordi</author></authors></contributors><titles><title>The Barcelona approach: diagnosis, staging, and treatment of hepatocellular carcinoma</title><secondary-title>Liver transplantation</secondary-title></titles><periodical><full-title>Liver transplantation</full-title></periodical><pages>S115-S120</pages><volume>10</volume><number>S2</number><dates><year>2004</year></dates><isbn>1527-6473</isbn><urls></urls></record></Cite></EndNote>(Llovet et al. 2004).MTA procedures are carried out under general anaesthesia and require the involvement of a qualified anaesthetist. For percutaneous MTA, a specialist interventional radiologist who is a qualified Fellow under the Royal College of Australian and New Zealand Radiologist (RANZCR) performs the ablative procedure. Interventional radiologists have generally performed subspecialist fellowship training to perform minimally invasive image guided interventions; however, this is not currently a requirement. The procedure is performed in the Radiology Department as imaging guidance with ultrasound and/or CT is routinely necessary.For intra-operative MTA, the procedure is undertaken in the operating theatre and is performed by the surgeon or an interventional radiologist at the same time as the resection procedure. The procedure involves accurate placement of the microwave antenna into the centre of the tumour under image guidance. Once placement is confirmed, the ablation is performed. Expert advice is that intra-operative US is used to guide open and laparoscopic MTA, while percutaneous US and/or CT may be used for percutaneous MTA procedures depending on a patient’s clinical presentation. Post procedure, patients are monitored by dedicated nursing staff for any immediate complications from the MTA procedure or anaesthesia. Follow up by the patient's treating specialist is performed with cross-sectional imaging between three and six weeks after the MTA.The most common adverse events associated with MTA are bleeding, damage to adjacent structures and infection. Advice from the applicant is that these would occur in less than five per cent of patients.Contraindications to MTA include patients who have (1) clinical evidence of liver failure, such as massive ascites or hepatic encephalopathy; (2) severe blood coagulation disorders (coagulopathy); (3) high intrahepatic tumor burden or high extrahepatic tumor burden; (4) acute or active inflammatory and infectious lesions in any organ; (5) acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction; (6) tumours located in close proximity to the gallbladder, diaphragm, gastrointestinal tract, pancreas, hepatic hilum or major bile duct or blood vessels; (7) and post-intervention hepatic reserve is likely to be too low due to the size and number of lesions PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MaWFuZzwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (Liang et al. 2013). Any contraindications to RFA are also contraindications to MTA (expert advice). Co-dependent informationServiceThere are no co-dependant services. MTA requires image guidance to locate the lesions to be ablated (US and/or CT). Advice from PASC is that imaging should be considered part of the intervention in line with MBS items for RFA and the current wording of the proposed items reflects this advice. PharmaceuticalThere is no co-dependent pharmaceutical medicine. General anaesthetic may be required and the item descriptor reflects the need to claim for this service.Medical device or prosthesisThere are no co-dependent devices or prostheses.Population eligible for the proposed medical serviceMedical condition relevant to the servicePrimary liver cancerThere are four main types of primary malignant liver lesions: HCC, cholangiocarcinoma (cancer of the bile ducts, CCA), angiosarcoma and hepatoblastoma. Of these, the most common is HCC, accounting for approximately 80 per cent of all primary liver cancers. Intrahepatic CCA accounts for between 10 and 20 per cent of primary liver cancers. Angiosarcoma and hepatoblastoma are very rare (each accounting for approximately one per cent of primary liver cancers) ADDIN EN.CITE <EndNote><Cite><Author>ASCO</Author><Year>2014</Year><RecNum>6</RecNum><DisplayText>(ASCO 2014)</DisplayText><record><rec-number>6</rec-number><foreign-keys><key app="EN" db-id="pf29a52tcz9eptepexavde2kpsarxr0aafvw" timestamp="1426114265">6</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>ASCO,</author></authors></contributors><titles><title>Liver Cancer</title></titles><volume>2014</volume><number>26 June</number><dates><year>2014</year></dates><publisher>American Society of Clinical Oncology</publisher><urls><related-urls><url>;(ASCO 2014)..HCC is the sixth most common cancer worldwide and the third most common cause of cancer-related death PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Gb3JuZXI8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (Forner et al. 2012; Lau 2000). In the majority of cases, HCC is caused by liver damage from infection (hepatitis C, B or D), toxins (primarily alcohol and aflatoxins) or metabolic disorders (diabetes and fatty liver disease) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Gb3JuZXI8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (Forner et al. 2012; Parikh and Hyman 2007).The incidence of HCC in Australia has more than doubled over the last 20 years, with an Australian age standardised incidence rate of 9.1 per 100,00 population in 2010 compared with 3.9 per 100,000 in 1990 ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>23</RecNum><DisplayText>(AIHW 2014)</DisplayText><record><rec-number>23</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1431475145">23</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author></authors></contributors><titles><title>Australian Health Statistics 2011-12</title><secondary-title>Health services series</secondary-title></titles><volume>2014</volume><number>26 June</number><dates><year>2014</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare,</publisher><isbn>Health services series 50. Cat. no. HSE 134.</isbn><urls><related-urls><url> June 2013</access-date></record></Cite></EndNote>(AIHW 2014). The wording of the proposed items allow for the treatment of any type of unresectable primary liver lesionsSecondary liver cancerMetastases in the liver are common to many types of primary cancer due to the liver’s dual blood supply and the presence of humoral factors which support cell growth ADDIN EN.CITE <EndNote><Cite><Author>Khan</Author><Year>2011</Year><RecNum>9</RecNum><DisplayText>(Khan and Karani 2011)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key app="EN" db-id="pf29a52tcz9eptepexavde2kpsarxr0aafvw" timestamp="1426114265">9</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Khan, A. N.</author><author>Karani, J.</author></authors></contributors><titles><title>Liver metastases imaging</title></titles><volume>2014</volume><number>27 June</number><dates><year>2011</year></dates><publisher>Medscape</publisher><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(Khan and Karani 2011). Liver metastases are reported to be 20 to 50 times more common than primary liver cancers ADDIN EN.CITE <EndNote><Cite><Author>Bree</Author><Year>2000</Year><RecNum>10</RecNum><DisplayText>(Bree et al. 2000)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="pf29a52tcz9eptepexavde2kpsarxr0aafvw" timestamp="1426114265">10</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bree, R. L.</author><author>Greene, F. L.</author><author>Ralls, P. W.</author><author>Balfe, D. M.</author><author>DiSantis, D. J.</author><author>Glick, S. N.</author><author>Kidd, R.</author><author>Levine, M. S.</author><author>Megibow, A. J.</author><author>Mezwa, D. G.</author><author>Saini, S.</author><author>Shuman, W. P.</author><author>Laine, L. A.</author><author>Lillemoe, K.</author></authors></contributors><auth-address>University of Missouri, Columbia, USA.</auth-address><titles><title>Suspected liver metastases. American College of Radiology. ACR Appropriateness Criteria</title><secondary-title>Radiology</secondary-title><alt-title>Radiology</alt-title></titles><periodical><full-title>Radiology</full-title><abbr-1>Radiology</abbr-1></periodical><alt-periodical><full-title>Radiology</full-title><abbr-1>Radiology</abbr-1></alt-periodical><pages>213-24</pages><volume>215 Suppl</volume><edition>2000/10/19</edition><keywords><keyword>Diagnosis, Differential</keyword><keyword>*Diagnostic Imaging</keyword><keyword>Humans</keyword><keyword>Liver/pathology</keyword><keyword>Liver Diseases/diagnosis</keyword><keyword>Liver Neoplasms/diagnosis/*secondary</keyword><keyword>Magnetic Resonance Imaging</keyword><keyword>Predictive Value of Tests</keyword><keyword>Tomography, X-Ray Computed</keyword><keyword>Ultrasonography</keyword></keywords><dates><year>2000</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>0033-8419 (Print)
0033-8419</isbn><accession-num>11037429</accession-num><urls></urls><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(Bree et al. 2000). Colorectal cancer (CRC) is the leading cause of malignancy in western countries, and the primary cause of hepatic metastases ADDIN EN.CITE <EndNote><Cite><Author>Ismaili</Author><Year>2011</Year><RecNum>11</RecNum><DisplayText>(Ismaili 2011; Sheth and Clary 2005)</DisplayText><record><rec-number>11</rec-number><foreign-keys><key app="EN" db-id="pf29a52tcz9eptepexavde2kpsarxr0aafvw" timestamp="1426114265">11</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ismaili, Nabil</author></authors></contributors><titles><title>Treatment of colorectal liver metastases</title><secondary-title>World J Surg Oncol</secondary-title></titles><periodical><full-title>World J Surg Oncol</full-title></periodical><pages>154</pages><volume>9</volume><dates><year>2011</year></dates><urls></urls></record></Cite><Cite><Author>Sheth</Author><Year>2005</Year><RecNum>12</RecNum><record><rec-number>12</rec-number><foreign-keys><key app="EN" db-id="pf29a52tcz9eptepexavde2kpsarxr0aafvw" timestamp="1426114266">12</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sheth, K. R.</author><author>Clary, B. M.</author></authors></contributors><auth-address>Division of Hepatobiliary Surgery, Duke University Medical Center, Durham, North Carolina</auth-address><titles><title>Management of Hepatic Metastases from Colorectal Cancer</title><secondary-title>Clin Colon Rectal Surg</secondary-title></titles><periodical><full-title>Clin Colon Rectal Surg</full-title></periodical><pages>215-23</pages><volume>18</volume><number>3</number><dates><year>2005</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>1531-0043 (Print)
1530-9681 (Electronic)</isbn><accession-num>20011304</accession-num><urls></urls><electronic-resource-num>10.1055/s-2005-916282</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(Ismaili 2011; Sheth and Clary 2005). In Australia and New Zealand, the age-adjusted annual incidence rate of CRC is 39.0 per 100,000 of the population ADDIN EN.CITE <EndNote><Cite><Author>Bala</Author><Year>2013</Year><RecNum>15</RecNum><DisplayText>(Bala et al. 2013)</DisplayText><record><rec-number>15</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1431304520">15</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bala, M. M.</author><author>Riemsma, R. P.</author><author>Wolff, R.</author><author>Kleijnen, J.</author></authors></contributors><auth-address>2nd Department of Internal Medicine, Jagiellonian University Medical College, 8 Skawinska St, Krakow, Poland, 31-066.</auth-address><titles><title>Microwave coagulation for liver metastases</title><secondary-title>Cochrane Database Syst Rev</secondary-title><alt-title>The Cochrane database of systematic reviews</alt-title></titles><periodical><full-title>Cochrane Database Syst Rev</full-title><abbr-1>The Cochrane database of systematic reviews</abbr-1></periodical><alt-periodical><full-title>Cochrane Database Syst Rev</full-title><abbr-1>The Cochrane database of systematic reviews</abbr-1></alt-periodical><pages>Cd010163</pages><volume>10</volume><edition>2013/10/15</edition><keywords><keyword>*Colorectal Neoplasms</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Liver Neoplasms/*secondary/*therapy</keyword><keyword>Male</keyword><keyword>Microwaves/*therapeutic use</keyword><keyword>Randomized Controlled Trials as Topic</keyword></keywords><dates><year>2013</year></dates><isbn>1361-6137</isbn><accession-num>24122576</accession-num><urls><related-urls><url>;(Bala et al. 2013). During the course of colorectal cancer up to 70 per cent of patients will develop hepatic metastases, and 20 to 25 per cent will present with metastases at the time of diagnosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OaWVrZWw8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (Niekel et al. 2010; Tsoulfas and Pramateftakis 2012). After CRC, the most common source of secondary liver tumours are neuroendocrine tumours which comprise almost 10 per cent of all liver metastases ADDIN EN.CITE <EndNote><Cite><Author>Lee</Author><Year>2012</Year><RecNum>33</RecNum><DisplayText>(Lee et al. 2012)</DisplayText><record><rec-number>33</rec-number><foreign-keys><key app="EN" db-id="f90p2ea5gf5wzbeprwwpa0fdawt9s0d9s05e" timestamp="1430369115">33</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lee, Ser Yee</author><author>Cheow, Peng Chung</author><author>Teo, Jin Yao</author><author>Ooi, London LPJ</author></authors></contributors><titles><title>Surgical treatment of neuroendocrine liver metastases</title><secondary-title>Int J Hep</secondary-title></titles><periodical><full-title>Int J Hep</full-title></periodical><pages>1</pages><volume>2012</volume><dates><year>2012</year></dates><isbn>2090-3448</isbn><urls></urls></record></Cite></EndNote>(Lee et al. 2012). Hepatic metastases occur in more than half of patients with primary neuroendocrine tumours ADDIN EN.CITE <EndNote><Cite><Author>Chamberlain</Author><Year>2000</Year><RecNum>34</RecNum><DisplayText>(Chamberlain et al. 2000)</DisplayText><record><rec-number>34</rec-number><foreign-keys><key app="EN" db-id="f90p2ea5gf5wzbeprwwpa0fdawt9s0d9s05e" timestamp="1430369115">34</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Chamberlain, R. S.</author><author>Canes, D.</author><author>Brown, K. T.</author><author>Saltz, L.</author><author>Jarnagin, W.</author><author>Fong, Y.</author><author>Blumgart, L. H.</author></authors></contributors><titles><title>Hepatic neuroendocrine metastases: does intervention alter outcomes?</title><secondary-title>J Am Coll Surgeons</secondary-title></titles><periodical><full-title>J Am Coll Surgeons</full-title></periodical><pages>432-445</pages><volume>190</volume><number>4</number><dates><year>2000</year></dates><isbn>1072-7515</isbn><urls></urls></record></Cite></EndNote>(Chamberlain et al. 2000). Non-neuroendocrine tumours, including breast carcinoma, renal carcinoma, gynaecological tumours, gastrointestinal stromal tumours, oesophageal carcinoma, gastric carcinoma, exocrine pancreatic carcinoma, lung cancer, melanoma and testicular tumours can also metastasise in the liver PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UcmVza2E8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (Bala et al. 2013; Treska et al. 2011). Of these, secondary breast cancer is the most common, with approximately 50 per cent of all patients with metastatic breast cancer developing secondary tumours in the liver.. Australian data on the exact number of each type of metastasis could not be obtained as these are recorded with the primary tumour. In an American autopsy study, lung, colon, pancreas, breast, and stomach were the most frequent sources of metastases to the liver, accounting for 24.8, 15.7, 10.9 , 10.1 and 6.1 per cent, respectively, of all patients with metastatic liver disease. Ovarian, endometrial, prostate, and urothelial carcinomas were less frequent sources of liver metastases, each accounting for 4% or less ADDIN EN.CITE <EndNote><Cite><Author>Centeno</Author><Year>2006</Year><RecNum>24</RecNum><DisplayText>(Centeno 2006)</DisplayText><record><rec-number>24</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1431478244">24</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Centeno, B.</author></authors></contributors><titles><title>Pathology of Liver Metastases</title><secondary-title>Cancer Control</secondary-title></titles><periodical><full-title>Cancer Control</full-title></periodical><pages>13-26</pages><volume>13</volume><number>1</number><dates><year>2006</year></dates><urls></urls></record></Cite></EndNote>(Centeno 2006).The proposed item wording for MTA of secondary liver tumours does not limit service provision to any type/s of primary tumour. Expert feedback is that ablative technologies are primarily used to treat CRC liver metastases. While ablation can hypothetically be used to treat other types of liver metastases, it is not routinely considered in the treatment algorithm due to the fact that; once liver metastases develop, disease is usually widely disseminated (Feedback from PASC).Proposed patient population and expected utilisationThere are three population groups proposed to be veligible for MTA treatment of liver lesionsPatients with unresectable primary liver lesions where MTA is used with curative intent.Patients with unresectable secondary liver lesions, without extra-hepatic spread, where MTA is used with curative intent.Patients with unresectable neuroendocrine liver metastases with or without extrahepatic spread who are refractory to somatostatin analogue therapy where MTA is used for palliative treatment of secretory syndromes.The applicant has suggested MTA is conducted in the following circumstances:When surgical resection is not possible due to the presence of liver malignancy in unresectable locations, the number and anatomical distribution of tumour lesions, and/or the presence of extrahepatic disease (metastatic neuroendocrine tumours only) or poor liver function ADDIN EN.CITE <EndNote><Cite><Author>Orloff</Author><Year>1981</Year><RecNum>123</RecNum><DisplayText>(Hemming and Gallinger 2001; Orloff 1981)</DisplayText><record><rec-number>123</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432788493">123</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Orloff, M.J,</author></authors></contributors><titles><title>Textbook of surgery: the biological basis of modern surgical practice</title></titles><edition>12th edn</edition><section>1131–1194</section><dates><year>1981</year></dates><pub-location>Pennsylvania</pub-location><publisher>W.B.Saunders Company</publisher><urls></urls></record></Cite><Cite><Author>Hemming</Author><Year>2001</Year><RecNum>124</RecNum><record><rec-number>124</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432788600">124</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Hemming, A.,</author><author>Gallinger, S.,</author></authors></contributors><titles><title>Surgery, Basic science and clinical evidence</title></titles><section>585–616</section><dates><year>2001</year></dates><pub-location>New York</pub-location><publisher>Springer-Verlag</publisher><urls></urls></record></Cite></EndNote>(Hemming and Gallinger 2001; Orloff 1981). Other contraindications to resection may include: patients whose hepatic metastases are unresectable due to medical comorbidities, such as low hepatic reserve, cardiac insufficiency, or poor performance status; patients with no or minimal extrahepatic disease; patients who have synchronous hepatic metastases; and patients whose hepatic metastases have recurred after resection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZWxpbnNvbjwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+
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ADDIN EN.CITE.DATA (Belinson et al. 2012; Belinson et al. 2013).If the proposed items are listed, advice from PASC is that MTA is expected to fully replace RFA. The most recent MBS data show that services for RFA (both percutaneous and intra-operative) were claimed 85 times in Australia in the 2013/14 financial year. The annual number of RFA services claimed has remained approximately stable since the 2009/10 financial year. Other potential ablative comparators are cryotherapy and percutaneous ethanol injection (PEI). MBS services for cryotherapy were claimed 11 times in 2013/14 financial year. PEI is not listed for use on the MBS and expert advice is that cryotherapy and PEI are rarely used in Australia.It is unclear how many RFA procedures were undertaken for patients with liver metastases in the private hospital sector as there is no MBS item for that service. The most recent AIHW hospital data show that RFA of the liver was performed 325 times in Australia in the 2012/13 financial year. ‘Other destruction of liver’ was used 72 times which could include MTA procedures being performed in public hospitals. This number has consistently increased since 2006 when 186 ablative procedures were performed ADDIN EN.CITE <EndNote><Cite><Author>AIHW National Hospital Morbidity Database</Author><Year>2014</Year><RecNum>126</RecNum><DisplayText>(AIHW National Hospital Morbidity Database 2014a)</DisplayText><record><rec-number>126</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432794015">126</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW National Hospital Morbidity Database,</author></authors></contributors><titles><title>Procedures and healthcare interventions (ACHI 7th edition), Australia, 2011?12 to 2012?13</title></titles><volume>2015</volume><number>20 May</number><dates><year>2014</year></dates><urls></urls></record></Cite></EndNote>(AIHW National Hospital Morbidity Database 2014a). For patients with liver metastases MTA may be delivered with or without adjuvant chemotherapy. Evidence for the population that would benefit from this serviceIn order to identify whether there is evidence for populations 1-3 described in this protocol; a literature search was conducted in PubMed. The search identified evidence relevant to patients with HCC and CRC metastases. Evidence may not be available for patients with other types of liver tumour that are included in the populations outlined in this protocol. Identified evidence is presented in REF _Ref420666084 \h Table 2 to REF _Ref420666087 \h Table 7.Table SEQ Table \* ARABIC 2Included systematic reviews on primary and secondary liver cancerStudy IDStudy typeLocationIncluded studiesInterventionsPopulationKey outcomesLahat et al. 2014SRIsrael1 level II study, 2 level III-3 studies on primary and secondary tumoursRFA, MTA and Nano knifePrimary and secondary tumoursA systematic review of complications after ablation reported on one observational study comparing RFA to MTA and two studies using MTA only. Major complication rates were found to be 4.1% and 4.6% for RFA and MTA, respectively. Meanwhile the minor complication rates were 5.9% and 5.7% for RFA and MTA. Overall, there was no statistically significant difference in the mortality rates, major complications, and minor complications between the RFA and MTA groups (P>0.05).Bhardwaj et al. 2010SRUK9 primary studies on HCC and CRCRFA, cryoablation, MTA; not all were comparative studiesHCC and CRC tumoursNine studies on MTA. Results suggest that survival in patients undergoing resection and ablation is similar to those patients undergoing hepatic resection only.Bertot et al. 2011SRJapan1 level II study and 1 level III study on primary and secondary tumoursRFA, PEI and MTAPrimary and secondary tumoursResults indicated that MTA is a safe technique in terms of mortality and major complication rate. However the results should be interpreted with caution because of being based on one large study.Boutros et al. 2010 SRUSA17 primary studies on HCC and CRCMTA v resection, other ablation or PEIHCC and CRC tumoursThe use of MTA with a 915MHz device with triple antennas is recommended over RFA for hepatic tumour ablation. Recurrence rates for lesions <3 cm, 3-year survival rates and major and minor complication are comparable between MTA and the current RFA literature, however data regarding tumours >3 cm and in close approximation to large vascular structures favoured MTA.Ong et al. 2009SRUK25 primary studies on primary and secondary tumoursRFA, resection; not all were comparative studiesPrimary and secondary tumoursSurvival rates comparable to surgical resection, however recurrence are rates higher than resection. Suitable in situations where resection is implausible, which is increasing. A useful addition to the currently available treatment options.Erce & Parks 2003SRUK8 primary studies on HCC and secondary tumoursCryoablation, RFA, MTA, ILP, ethanol ablation, other injectionsHCC and CRC tumoursAt this time, MTA of liver had primarily been used to treat HCC. Complete necrosis is possible in tumours <2cm. Recurrence was low.Garcea et al. 2003SRUK2 primary studies on primary and secondary tumoursTen types of ablationPrimary and secondary tumoursStudies on treatment of secondary and primary cancer with PEI, percutaneous acetic acid injection, other percutaneous injections, RFA, high-intensity focused ultrasound (HIFU), interstitial laser photocoagulation (ILP), MTA, electrolysis and cryotherapy. Two studies reported on MTA use in the liver. Fair therapeutic results were achieved with MTA in lesions of 30 mm or less, and in well differentiated HCCs. HCC = hepatocellular carcinoma; HIFU = high-intensity focused ultrasound; ILP = interstitial laser photocoagulation; MHz = Megahertz; MTA = microwave tissue ablation; PEI = percutaneous ethanol injection; RFA = radiofrequency ablation; SR = systematic review; UK = United Kingdom; USA = United States of AmericaTable SEQ Table \* ARABIC 3Included systematic reviews on primary liver cancerStudy IDStudy typeLocationEvidence level of included studiesInterventionsPopulationKey outcomesWeiss et al. 2013SRGermany1 level II study on HCCRFA, resection*, PEI, laser ablation and MTAHCCIncluded one RCT on RFA versus microwave ablation (one trial, 72 participants). No significant difference was found between RFA and percutaneous MTA regarding local progression. Rate of complications in both groups was low.*Included Shibata et al. 2002 only; HCC = hepatocellular carcinoma; ILP = interstitial laser photocoagulation; MTA = microwave tissue ablation; PEI = percutaneous ethanol injection; RCT = randomised controlled trial; RFA = radiofrequency ablation; SR = systematic reviewTable SEQ Table \* ARABIC 4Included systematic reviews on secondary liver cancerStudy IDStudy typeLocationEvidence level of included studiesInterventionsPopulationKey outcomesLoveman et al. 2014SRUK1 Level II study, 1 level IV study on secondary tumoursResection*, MTASecondary tumoursThere is currently limited high-quality research evidence upon which to base any firm decisions regarding ablative therapies for liver metastases. One RCT of microwave ablation versus surgical resection was identified and showed no improvement in outcomes compared with resection.Bala et al. 2013Cochrane SREurope1 Level 1 study on secondary tumoursResection*, MTASecondary tumoursOn the basis of one RCT, which had methodological limitations, evidence is insufficient to show whether MTA brings any significant benefit in terms of survival or recurrence compared with conventional surgery for patients with liver metastases from CRC. The number of adverse events, except for the requirement for blood transfusion, which was more common in the liver resection group, was similar in both groups. At present, microwave therapy cannot be recommended outside randomised clinical trials.Pathak et al. 2011SRUK1 level I, 1 level II, 11 level III-2 on CRCCryotherapy, chemotherapy and MTA; not all were comparative studiesCRCThis systematic review on treatments for CRC found thirteen studies on MTA. Concluded ablative therapies (cryotherapy and MTA) offer significantly improved survival compared with palliative chemotherapy alone. Complication rates are low. For MTA 1-, 3- and 5-year survival rates were 40–91.4%, 0–57% and 14–32%. The major complication rate was 0–19%. Median survival was 20.5–43 months, with a local recurrence rate of 2–12.5%.*Included Shibata et al. 2000 primarily in analysis; CRC = colorectal cancer; MTA = microwave tissue ablation; RCT = randomised controlled trial; RFA = radiofrequency ablation; SR = systematic review; UK = United KingdomTable SEQ Table \* ARABIC 5Included randomised controlled trials on primary liver cancerStudy IDStudy typeLocationpopulationInterventionComparatorKey outcomesMethodShibata et al 2002.RCT72 patients with 94 HCC nodulesRFANo statistically significant differences between the treatments for therapeutic effect, major complications or rates of residual foci of untreated disease. The number of treatment sessions per nodule was significantly lower for the RFA group.percutaneousHCC = hepatocellular carcinoma; RCT = randomised controlled trial; RF A= radiofrequency ablation; Table SEQ Table \* ARABIC 6Included randomised controlled trial on secondary liver cancerStudy IDStudy typeLocationpopulationInterventionComparatorKey outcomesMethodShibata et al. 2000RCT30 patients with multiple metastatic CRCresectionNo statistically significant difference in 1-, 2- and 3-year survival rates between treatments. Statistically significant lower level of blood loss in MTA treatment.laparoscopicCRC = colorectal cancer; MTA = microwave tissue ablation; RCT = randomised controlled trial Table SEQ Table \* ARABIC 7Other studies of interestStudy IDStudy typeLocationIncluded studiesPopulationInterventionComparatorKey outcomesBlue Cross Blue Shield 2013ReviewUSA2 level I, 1 level II, 2 level III-2 and 4 level IV (9 studies in total) including patients with HCC onlyFor the 1 level II and the 2 level III-2 studies the comparator was RFAThe RCT comparing RFA to MTA reported no significant differences between the techniques in the rate of untreated disease during follow-up or major complication rate. The number of treatment sessions required per nodule was significantly lower in the RFA group; however the treatment time per session was significantly higher than for MTA. One of the non-randomised comparative studies (MTA versus RFA) reported no significant differences between MTA and RFA for complete ablation, local tumour recurrence, major complications or disease-free survival at 1, 2 and 3 years. The other reported no significant differences in tumour ablation volumes between MTA and RFA but that operative times were shorter in the MTA group. One of the level IV studies reported that a significantly higher rate of major complications and more ablation sessions were experienced when a non-cooled shaft antenna was used than when newer technology involving cooled-shaft antennas were used.Liang et al. 2013GuidelinesChinaNRNRThis article outlines the first CPG ultrasound-guided percutaneous microwave ablation therapy for liver cancer. Describes MTA mechanism, techniques, equipment, indications, contraindications, patient preparation and aftercare, combined treatment with other modalities, follow-up and assessment of therapeutic efficacy.Blue Cross Blue Shield 2012ReviewUSA6 level I, II and IV studies on patients with CRC onlyMTA v RFAOne of the three systematic reviews reported results for liver metastases separately. This review, which included 13 studies with a total of 406 patients, reported mean survival rate of 73%, 30% and 16% at 1-, 3- and 5- years respectively. The authors of this systematic review recognized the limitations in the available evidence base but felt survival rates following MTA were favourable in comparison to palliative chemotherapy alone. The RCT* found non-significant differences in survival rates and mean disease-free survival. Intra-operative blood loss and the need for blood transfusion were significantly lower in the MTA group compared with the resection group where 6 patients required blood transfusion. Two case series studies, one retrospective (n=39) the other prospective (n=100), reported high rates of complete ablation and low rates of major complications.NICE 2011GuidelinesUK8 studies on secondary tumoursMTA v resectionSurvival and tumour response were measured. 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ADDIN EN.CITE.DATA (Bala et al. 2013; Bertot et al. 2011; Bhardwaj et al. 2010; Boutros et al. 2010; Erce and Parks 2003; Garcea et al. 2003; Lahat et al. 2014; Loveman et al. 2014; Ong et al. 2009; Pathak et al. 2011; Weis et al. 2013). There is significant overlap between the systematic reviews and most of the included studies were level III studies ADDIN EN.CITE <EndNote><Cite><Author>NHMRC</Author><Year>2009</Year><RecNum>128</RecNum><DisplayText>(NHMRC 2009)</DisplayText><record><rec-number>128</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432868822">128</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NHMRC</author></authors></contributors><titles><title>NHMRC levels of evidence and grades for recommendations for developers of guidelines</title></titles><volume>2014</volume><number>2 Decemeber</number><dates><year>2009</year></dates><pub-location>Canberra</pub-location><publisher>NHMRC</publisher><urls><related-urls><url>;(NHMRC 2009). A total of two RCTs were identified. One included patients with HCC and compared MTA to RFA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGliYXRhPC9BdXRob3I+PFllYXI+MjAwMjwvWWVhcj48
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ADDIN EN.CITE.DATA (Shibata et al. 2002).The second RCT included patients with CRC liver metastases and compared MTA to liver resection ADDIN EN.CITE <EndNote><Cite><Author>Shibata</Author><Year>2000</Year><RecNum>30</RecNum><DisplayText>(Shibata et al. 2000)</DisplayText><record><rec-number>30</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1431587211">30</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Shibata, T.</author><author>Niinobu, T.</author><author>Ogata, N.</author><author>Takami, M.</author></authors></contributors><auth-address>Department of Surgery, Toyonaka Municipal Hospital, Osaka, Japan.</auth-address><titles><title>Microwave coagulation therapy for multiple hepatic metastases from colorectal carcinoma</title><secondary-title>Cancer</secondary-title><alt-title>Cancer</alt-title></titles><periodical><full-title>Cancer</full-title><abbr-1>Cancer</abbr-1></periodical><alt-periodical><full-title>Cancer</full-title><abbr-1>Cancer</abbr-1></alt-periodical><pages>276-84</pages><volume>89</volume><number>2</number><edition>2000/08/05</edition><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Aged, 80 and over</keyword><keyword>Colorectal Neoplasms/blood/*pathology</keyword><keyword>Electrocoagulation/adverse effects/*methods</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Liver Neoplasms/blood/*secondary/*surgery</keyword><keyword>Male</keyword><keyword>Microwaves/adverse effects/*therapeutic use</keyword><keyword>Middle Aged</keyword><keyword>Survival Analysis</keyword></keywords><dates><year>2000</year><pub-dates><date>Jul 15</date></pub-dates></dates><isbn>0008-543X (Print)
0008-543x</isbn><accession-num>10918156</accession-num><urls></urls><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(Shibata et al. 2000). In addition to the controlled trials, the search identified 33 potentially relevant non-randomised comparative studies with patient numbers between 18 and 879 patients and 44 potentially relevant single arm studies. These are listed in REF _Ref420916643 \h Appendix A: potentially relevant literature.Other studies of interest include NICE ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1"><Author>NICE</Author><Year>2011</Year><RecNum>32</RecNum><DisplayText>(2011)</DisplayText><record><rec-number>32</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432094718">32</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NICE,</author></authors></contributors><titles><title>NICE interventional procedure guidance [IPG406]: Microwave ablation for the treatment of liver metastases</title></titles><volume>2015</volume><number>20 May</number><dates><year>2011</year></dates><publisher>NICE</publisher><urls><related-urls><url>;(2011), a UK clinical practice guideline and an article by Liang et al. PEVuZE5vdGU+PENpdGUgRXhjbHVkZUF1dGg9IjEiPjxBdXRob3I+TGlhbmc8L0F1dGhvcj48WWVh
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ADDIN EN.CITE.DATA (Chinnaratha et al. 2015), 2450MHz of radiation is used at a maximum power output of 140W. This is in conformance with what is used in Asian studies, with microwave devices in the 2GHz range. Machines with both ranges are available in Australia. It is unknown whether these different machines results in different clinical outcomes.Clinical TrialsThere are nine clinical trials reported to be currently underway (Clinical trials website). Two relevant publications have come from them, a non-randomized trial on MTA of secondary liver cancer, and a prospective cohort study on using PET-MRI after ablation. Most other current trials are single arm. They concern primary (3), secondary (3) and both primary and secondary (3) liver cancers. Completion dates range from Apr 2009 to Dec 2017. REF _Ref420588517 \h Table 8 displays key information on current clinical trials.Table SEQ Table \* ARABIC 8Current clinical trialsClinical trialStatusStudy typeCompletion datePublished articlesSingle-probe Microwave Ablation (MWA) of Metastatic Liver Cancer - secondaryCompletedNon-randomized trialApr 2009Hompes et al. 2010Laparoscopic Microwave Ablation and Portal Vein Ligation for Staged Hepatectomy (LAPS) - bothRecruitingSingle arm trialJune 201610 – not MTA relatedFreehand Ultrasound Elasticity Imaging in Liver Surgery - bothUnknownSingle arm trialSept2011NoneAdvanced Image Guidance Utilized in Liver Surgery - PrimaryCompletedSingle arm trialSept 2013NonePET-MRI After Radiofrequency Ablation (RFA) or Microwave Ablation (MWA) – SecondaryRecruitingProspective cohort studyJan2015Nielsen et al 2014Microwave Ablation of Resectable Liver Tumours - PrimaryUnknownProspective observational studyApr2015NoneEffectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation - PrimaryRecruitingPhase 3 randomized controlled trialOct 2015NoneFusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms - bothRecruitingSingle arm trialJan20163 – not MTA relatedLOTCOL Study: Local Treatment of Colo-rectal Liver Met - SecondaryRecruitingSingle arm trialDec2017NoneRFA = radiofrequency ablation; MTA = microwave tissue ablation; MWA = microwave ablation; LAPS = Ligation for Staged HepatectomyComparatorComparator for population 1Current clinical management of patients with unresectable primary liver lesions is treatment by radiofrequency ablation (RFA). MBS item descriptors for RFA of unresectable HCC lesions are presented in REF _Ref420588575 \h \* MERGEFORMAT Table 9 and REF _Ref420668653 \h Table 10. There are no MBS items to cover RFA of other primary liver lesions. Advice from the applicant and PASC is that MTA is expected to fully replace RFA if the proposed items are listed. Table SEQ Table \* ARABIC 9MBS item for percutaneous radiofrequency ablationCategory 3 - THERAPEUTIC PROCEDURESMBS 50950NONRESECTABLE HEPATOCELLULAR CARCINOMA, destruction of, by percutaneous radiofrequency ablation, including any associated imaging services, not being a service associated with a service to which item 30419 or 50952 appliesFee: $817.10[Relevant explanatory notes]Table SEQ Table \* ARABIC 10MBS item for open or laparoscopic radiofrequency ablationCategory 3 - THERAPEUTIC PROCEDURESMBS 50952 NON RESECTABLE HEPATOCELLULAR CARCINOMA, destruction of, by open or laparoscopic radiofrequency ablation, where a multi-disciplinary team has assessed that percutaneous radiofrequency ablation cannot be performed or is not practical because of one or more of the following clinical circumstances: - percutaneous access cannot be achieved; - vital organs/tissues are at risk of damage from the percutaneous RFA procedure; or - resection of one part of the liver is possible however there is at least one primary liver tumour in a non-resectable region of the liver which is suitable for radiofrequency ablation, including any associated imaging services, not being a service associated with a service to which item 30419 or 50950 appliesFee: $817.10[Relevant explanatory notes]The RFA procedure involves placing a monopolar electrode into target tissue, using the 375-480 kHz frequency of current which will follow the path of lowest impedance through the circuit. Ablation can occur at any point along the closed circuit through the patient PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MbG95ZDwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (Lloyd et al. 2011).Resources used in the delivery of RFA will be similar to those needed for MTA. Imaging is required to diagnose and locate the liver tumours. Hospital admission, radiology suite, general anaesthesia, other consumables and the time of the interventional radiologist are used.RFA is performed as an inpatient procedure requiring an overnight stay for open or laparoscopic RFA. For percutaneous service delivery; the procedure may be a day-surgery procedure or require an overnight stay depending on the patient’s age, time of day at which the procedure is undertaken, anaesthetic type, procedure duration and comorbidities.Expert advice is that cryotherapy (MBS item no. 30419) and PEI (not listed on the MBS) are rarely used in Australia and are therefore are not considered as parator for population 2Advice from the applicant and PASC is that the comparators for population 2 are RFA (with or without adjuvant chemotherapy) and chemotherapy. RFA is not currently listed on the MBS for use in this population. Comparator for population 3Advice from the applicant and PASC is that the comparators for population 3 are RFA (with or without adjuvant chemotherapy), chemotherapy, chemoembolisation, radioembolisation, radiolabelled somatostatin analogue therapy, or resection (rarely). RFA is not currently listed on the MBS for use in this population. Clinical management algorithmCurrent clinical practice – Population 1Chemo = chemotherapy; HCC = hepatocellular carcinoma; Perc = percutaneous; RFA = radiofrequency ablationProposed clinical practice – Population 1Chemo = chemotherapy; HCC = hepatocellular carcinoma; Perc = percutaneous; MTA = microwave tissue ablation; RFA = radiofrequency ablationCurrent clinical practice – Population 2Chemo = chemotherapy; Perc = percutaneous; RFA = radiofrequency ablationProposed clinical practice – Population 2Chemo = chemotherapy; Perc = percutaneous; MTA = microwave tissue ablation; RFA = radiofrequency ablationCurrent clinical practice – Population 3CE = chemoembolization, Chemo = chemotherapy; Perc = percutaneous; RE = radioembolization, RFA = radiofrequency ablationProposed clinical practice – Population 3CE = chemoembolization, Chemo = chemotherapy; Perc = percutaneous; RE = radioembolization, RFA = radiofrequency ablationIn the above clinical practice algorithms, MTA is introduced as a replacement for RFA (either percutaneous or intra-operative). It is proposed that the same patients would be eligible for both types of ablation and that no additional patients would be treated under the proposed pathways. A total of 2,834 patients were diagnosed with HCC in the 2012/13 financial year ADDIN EN.CITE <EndNote><Cite><Author>AIHW National Hospital Morbidity Database</Author><Year>2014</Year><RecNum>125</RecNum><DisplayText>(AIHW National Hospital Morbidity Database 2014b)</DisplayText><record><rec-number>125</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432793769">125</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW National Hospital Morbidity Database,</author></authors></contributors><titles><title>Separation statistics by principal diagnosis (ICD?10?AM 7th edition), Australia, 2011?12 to 2012?13</title></titles><volume>2015</volume><number>19 May</number><dates><year>2014</year></dates><urls><related-urls><url>;(AIHW National Hospital Morbidity Database 2014b). Data from an epidemiology study in the Northern Territory showed that of 80 cases diagnosed between 2000 and 2011, 42 patients (53%) received palliative care. Of the remaining 38 patients, three (8%) underwent liver transplantation, 12 (32%) had liver resection, seven (18%) had RFA, eight (21%) had TACE and 10 (26%) received chemotherapy with sorafenib. Two patients received more than one intervention ADDIN EN.CITE <EndNote><Cite><Author>Parker</Author><Year>2014</Year><RecNum>33</RecNum><DisplayText>(Parker et al. 2014)</DisplayText><record><rec-number>33</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432166893">33</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Parker, Christopher</author><author>Tong, S</author><author>Dempsey, Karen</author><author>Condon, John</author><author>Sharma, Suresh K</author><author>Chen, J</author><author>Sievert, William</author><author>Davis, Joshua S</author></authors></contributors><titles><title>Hepatocellular carcinoma in Australia's Northern Territory: high incidence and poor outcome</title><secondary-title>The Medical journal of Australia</secondary-title></titles><periodical><full-title>The Medical journal of Australia</full-title></periodical><pages>470-474</pages><volume>201</volume><number>8</number><dates><year>2014</year></dates><isbn>0025-729X</isbn><urls></urls></record></Cite></EndNote>(Parker et al. 2014). The Applicant has advised that this is broadly representative of the Australian population.Expert advice is that percutaneous tumour ablation is rarely performed in patients with liver metastases. For patients with liver metastases and extra-hepatic spread, expert advice is that tumour ablation would only rarely be performed in patients with neuroendocrine tumours as a palliative procedure to reduce symptoms associated with secretory syndromes. The main treatment option for patients with liver metastases and extra-hepatic spread is management by chemotherapy.Expected health outcomesExpected patient-relevant health outcomesFor patients who have MTA as a ‘curative’ procedure, the following outcomes are relevant ADDIN EN.CITE <EndNote><Cite><Author>NICE</Author><Year>2007</Year><RecNum>31</RecNum><DisplayText>(NICE 2007; NICE 2011)</DisplayText><record><rec-number>31</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432094454">31</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NICE,</author></authors></contributors><titles><title>NICE interventional procedure guidance [IPG214]: Microwave ablation of hepatocellular carcinoma</title></titles><volume>2015</volume><number>20 May</number><dates><year>2007</year></dates><publisher>NICE</publisher><urls><related-urls><url> app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432094718">32</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NICE,</author></authors></contributors><titles><title>NICE interventional procedure guidance [IPG406]: Microwave ablation for the treatment of liver metastases</title></titles><volume>2015</volume><number>20 May</number><dates><year>2011</year></dates><publisher>NICE</publisher><urls><related-urls><url>;(NICE 2007; NICE 2011):Primary effectiveness:Tumour recurrencePercentage of lesions with complete ablationOverall survival (short term and long-term)Recurrence free survival (short term and long-term)Need for repeat ablationAccuracy of ablation marginsSecondary effectiveness:Procedure timeLength of hospital stayRecovery timePatient discomfortQuality of lifePrimary safetyRates of adverse events associated with the intervention and comparator potential risks are discussed in the following section)For patients who have MTA as a ‘palliative’ procedure the following primary effectiveness outcomes are relevant:Symptom reductionQuality of life measuresMedian survival timePotential risks to patientsComplications associated with MTA and RFA include ADDIN EN.CITE <EndNote><Cite><Author>NICE</Author><Year>2007</Year><RecNum>31</RecNum><DisplayText>(NICE 2007; NICE 2011)</DisplayText><record><rec-number>31</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432094454">31</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NICE,</author></authors></contributors><titles><title>NICE interventional procedure guidance [IPG214]: Microwave ablation of hepatocellular carcinoma</title></titles><volume>2015</volume><number>20 May</number><dates><year>2007</year></dates><publisher>NICE</publisher><urls><related-urls><url> app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432094718">32</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NICE,</author></authors></contributors><titles><title>NICE interventional procedure guidance [IPG406]: Microwave ablation for the treatment of liver metastases</title></titles><volume>2015</volume><number>20 May</number><dates><year>2011</year></dates><publisher>NICE</publisher><urls><related-urls><url>;(NICE 2007; NICE 2011):Bleeding (intra-abdominal and gastrointestinal)Bile duct injury or stenosisWound dehiscencePainPost-operative ascitesSkin burnsVagovagal reflexLiver abscessHepatic infarctionColonic perforationDeterioration in liver functionDamage to adjacent organs (kidney, lung, heart)PneumothoraxPleural effusionFeverTumour tract seeding (risk may be reduced by tract ablation)Advice from the applicant is that the most common adverse events associated with MTA are bleeding, damage to surrounding tissue and infection. 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ADDIN EN.CITE.DATA (Bhardwaj et al. 2010).In addition, MTA is claimed to have a steeper temperature gradient, with tissue temperatures reaching > 200 degrees Celsius, and faster conduction than RFA ADDIN EN.CITE <EndNote><Cite><Author>Simo</Author><Year>2012</Year><RecNum>120</RecNum><DisplayText>(Simo et al. 2012)</DisplayText><record><rec-number>120</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432788156">120</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Simo, KA.</author><author>Tsirline, V.B.</author><author>Sindram, D.</author><author>McMillan, M.T.</author><author>Thompson, K.J.</author><author>Swan, R.Z.</author><author>McKillop, I.H.</author><author>Martinie, J.B.</author><author>Iannitti, D.A.</author></authors></contributors><titles><title>Microwave ablation using 915-MHz and 2.45-GHz systems: what are the differences?</title><secondary-title>HPB (Oxford)</secondary-title></titles><periodical><full-title>HPB (Oxford)</full-title><abbr-1>HPB : the official journal of the International Hepato Pancreato Biliary Association</abbr-1></periodical><dates><year>2012</year></dates><urls></urls><electronic-resource-num>10.1111/hpb.12081 </electronic-resource-num></record></Cite></EndNote>(Simo et al. 2012). This allows for larger ablation volumes in faster times of 4-6 minutes in contrast to 10-20 minutes (Swan et al. 2012).The applicant has also advised that there is a lower risk of complications with MTA compared to RFA as MTA does not involve electricity or grounding pads. This removes the risk of sustaining burns from the grounding pads PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2h1dHQ8L0F1dGhvcj48WWVhcj4yMDA5PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (Bhardwaj et al. 2010).Economic evaluationOn the basis of the clinical claim, a cost-effectiveness/cost-utility analysis should be provided.Decision analyticTable SEQ Table \* ARABIC 11Summary of PICO to define the research question(s) for Population 1PICO CriteriaCommentsPatientsPatients with unresectable primary liver lesionsInterventionMicrowave tissue ablation (MTA) of the liver (percutaneous OR laparoscopic/open)ComparatorRadiofrequency ablation (RFA) of the liver (percutaneous OR laparoscopic/open)OutcomesPrimary effectiveness: tumour recurrence, percentage of lesions with complete ablation, overall survival (short term and long-term), recurrence free survival (short term and long-term), need for repeat ablation, accuracy of ablation margins. Secondary effectiveness: procedure time, length of hospital stay, recovery time, patient discomfort, quality of life.Safety: rate of adverse events including (bleeding, bile duct injury or stenosis, wound dehiscence, pain, post-operative ascites, skin burns, liver abscess, hepatic infarction, colonic perforation, deterioration in liver function, damage to adjacent organs, pneumothorax, pleural effusion, and fever), procedure related mortality.In patients with unresectable primary liver lesions, what are the safety, effectiveness and cost effectiveness of percutaneous MTA compared to RFA?In patients with unresectable primary liver lesions, what are the safety, effectiveness and cost effectiveness of open or laparoscopic MTA compared to RFA?Table SEQ Table \* ARABIC 12:Summary of PICO to define the research question(s) for Population 2PICO CriteriaCommentsPatientsPatients with unresectable metastatic liver disease without extrahepatic spreadInterventionMicrowave tissue ablation (MTA) of the liver (percutaneous OR laparoscopic/open) with curative intent, with or without adjuvant chemotherapyComparatorRadiofrequency ablation (RFA) of the liver (percutaneous OR laparoscopic/open) (with or without chemotherapy)ChemotherapyOutcomesPrimary effectiveness: tumour recurrence, percentage of lesions with complete ablation, overall survival (short term and long-term), recurrence free survival (short term and long-term), need for repeat ablation, accuracy of ablation margins. Secondary effectiveness: procedure time, length of hospital stay, recovery time, patient discomfort, quality of life.Safety: rate of adverse events including (bleeding, bile duct injury or stenosis, wound dehiscence, pain, post-operative ascites, skin burns, liver abscess, hepatic infarction, colonic perforation, deterioration in liver function, damage to adjacent organs, pneumothorax, pleural effusion, and fever), procedure related mortality.In patients with unresectable liver metastases without extrahepatic spread, what are the safety, effectiveness and cost effectiveness of percutaneous MTA with curative intent (with or without chemotherapy) of liver tumours compared to RFA, chemotherapy or both?In patients with unresectable liver metastases without extrahepatic spread, what are the safety, effectiveness and cost effectiveness of open or laparoscopic MTA with curative intent (with or without chemotherapy) of liver tumours compared to RFA, chemotherapy or both?Table SEQ Table \* ARABIC 13:Summary of PICO to define the research question(s) for Population 3PICO CriteriaCommentsPatientsPatients with unresectable neuroendocrine liver lesions, with extrahepatic spread, refractory to somatostatin analogues requiring palliative treatment for secretory syndromes. InterventionMicrowave tissue ablation (MTA) of the liver (percutaneous OR laparoscopic/open)ComparatorRadiofrequency ablation (RFA) of the liver (percutaneous OR laparoscopic/open) ChemotherapyChemoembolizationRadioembolizationRadiolabelled somatostatin analogue therapyResection (rare)OutcomesPrimary effectiveness: symptom reduction, quality of life, median survivalSafety: rate of adverse events including (bleeding, bile duct injury or stenosis, wound dehiscence, pain, post-operative ascites, skin burns, liver abscess, hepatic infarction, colonic perforation, deterioration in liver function, damage to adjacent organs, pneumothorax, pleural effusion, and fever)In patients with unresectable neuroendocrine liver metastases (with or without extrahepatic spread) with secretory syndromes refractory to somatostatin analogues requiring palliative treatment , what is the safety, effectiveness and cost effectiveness of percutaneous MTA of liver tumours compared to RFA, chemotherapy, chemoembolisation, radioembolisation, radiolabelled somatostatin analogue therapy or resection?In patients with unresectable neuroendocrine liver metastases (with or without extrahepatic spread) with secretory syndromes refractory to somatostatin analogues requiring palliative treatment , what is the safety, effectiveness and cost effectiveness of open or laparoscopic MTA of liver tumours compared to RFA, chemotherapy, chemoembolisation, radioembolisation, radiolabelled somatostatin analogue therapy or resection?Fee for the proposed medical serviceType of funding proposed for this serviceThe following wording for the proposed MBS items for MTA has been suggested in line with the current items for RFA of the liver (50950 and 50952):Table SEQ Table \* ARABIC 14Proposed MBS Item for percutaneous microwave tissue ablation, unresectable HCCCategory 3 - THERAPEUTIC PROCEDURESMBS [item number]NONRESECTABLE PRIMARY LIVER LESIONS, destruction of, by percutaneous microwave tissue ablation, including any associated imaging services, not being a service associated with a service to which items 30419, 50950, 50952 or (other MTA items) appliesFee: $TBA[Relevant explanatory notes if required]Table SEQ Table \* ARABIC 15Proposed MBS Item for open or laparoscopic microwave tissue ablation, unresectable HCCCategory 3 - THERAPEUTIC PROCEDURESMBS [item number]NONRESECTABLE PRIMARY LIVER LESIONS, destruction of, by open or laparoscopic microwave tissue ablation, including any associated imaging services, where a multi-disciplinary team has assessed that percutaneous microwave ablation cannot be performed or is not practical because of one or more of the following clinical circumstances: - percutaneous access cannot be achieved; - vital organs/tissues are at risk of damage from the percutaneous MTA procedure; or - resection of one part of the liver is possible however there is at least one primary liver tumour in a non-resectable region of the liver which is suitable for microwave ablation, including any associated imaging services, not being a service associated with a service to which items 30419, 50950, 50952 or (other MTA items) appliesFee: $TBA[Relevant explanatory notes if required]Table SEQ Table \* ARABIC 16Proposed MBS Item for percutaneous microwave tissue ablation, unresectable metastatic liver tumoursCategory 3 - THERAPEUTIC PROCEDURESMBS [item number]NONRESECTABLE METASTATIC LIVER LESIONS, destruction of, by percutaneous microwave tissue ablation, including any associated imaging services, not being a service associated with a service to which items 30419, 50950, 50952 or (other MTA items) appliesFee: $TBA[Relevant explanatory notes if required]Table SEQ Table \* ARABIC 17Proposed MBS Item for open or laparoscopic microwave tissue ablation, unresectable metastatic liver tumoursCategory 3 - THERAPEUTIC PROCEDURESMBS [item number]NONRESECTABLE METASTATIC LIVER LESIONS, destruction of, by open or laparoscopic microwave tissue ablation, including any associated imaging services, where a multi-disciplinary team has assessed that percutaneous microwave ablation cannot be performed or is not practical because of one or more of the following clinical circumstances: - percutaneous access cannot be achieved; - vital organs/tissues are at risk of damage from the percutaneous MTA procedure; or - resection of one part of the liver is possible however there is at least one primary liver tumour in a non-resectable region of the liver which is suitable for microwave ablation, including any associated imaging services, not being a service associated with a service to which items 30419, 50950, 50952 or (other MTA items) appliesFee: $TBA[Relevant explanatory notes if required]The applicant has advised that the phrase “including all associated imaging” would preclude the claiming of other imagining items in association with the proposed items for MTA. Advice from PASC is that imaging should be considered part of the intervention as with items for RFA and should not be claimed separately.Direct costs associated with the proposed service Many of the following costs will need to be identified during the assessment phase.MTA equipment – including: cost of machine $50,000 and applicator $2,960, other associated costs (trolley, temperature probe) (source: application documents)Interventional radiologist, time (percutaneous procedures)Surgeon, time (open or laparoscopic procedures)Radiology suite or operating theatre usageOther consumables, e.g. dressingsAnaestheticAnaesthetist, timeFollow-up imagingDedicated nursing staff for post-intervention careOvernight stay in hospitalProposed feeThe applicant has proposed the following fee structure:“A $1300 fee for ablation of 2-3 lesions, a $1600 fee for ablation of 4-5 lesions and a $2000 fee for ablation of >5 lesions. The higher fee for >5 lesions reflects the increased risk to the patients such as collateral damage as well as more skill, time and expertise required of the physican to ensure better patient outcomes”The fee for RFA services (both percutaneous (50950) and open/laparoscopic (50952)) is $817.10. It should be noted, there are claims MTA has a faster ablation time ADDIN EN.CITE <EndNote><Cite><Author>Swan</Author><Year>2012</Year><RecNum>34</RecNum><DisplayText>(Swan et al. 2012)</DisplayText><record><rec-number>34</rec-number><foreign-keys><key app="EN" db-id="dadtwfzd5we2t6e5aw2v92d25detaaawse92" timestamp="1432260904">34</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Swan, R. Z.</author><author>Tsirline, V.</author><author>Sindram, D.</author><author>Martinie, J. B.</author><author>Iannitti, D. A.</author></authors></contributors><titles><title>Fundamentals of microwave physics: application to hepatic ablation</title><secondary-title>J Microwave Surg</secondary-title></titles><periodical><full-title>J Microwave Surg</full-title></periodical><volume>30</volume><dates><year>2012</year></dates><urls></urls></record></Cite></EndNote>(Swan et al. 2012) which would result in less time overall spent in the radiology suite, and may impact on the cost of the procedure.PASC has agreed that graduated fees for up to five lesions should be considered in the assessment phase. PASC has advised that the assessment phase should include a stratified survival analysis based on the number of ablated lesions.Regulatory informationThe application does not specify the type of MTA device to be used. Under the wording of the proposed items any MTA machine listed on the ARTG could be used in conjunction with the procedure being claimed. MTA devices registered in Australia include:The Acculis MTA system consists of the Sulis VpMTA Generator, Acculis Local Control Station (LCS), Accu2i pMTA Applicators and optional MTA Temperature Probes. Temperature Probes: 174513Trolley: 195697Applicator: 174514Microwave System: 157722 TGA-approved indication(s) or purpose(s): Temperature Probes: The temperature probes used with the Acculis MTA System are intended to monitor the temperature of the probes at the point of delivery of the microwave energy (i.e.: at the point of tissue coagulation).Trolley: A general-purpose trolley or conveyance designed for transporting/supplying any kind of devices, medical equipment or goods within a department or hospital. It may have one or more shelvesApplicator: The Single Use Microwave Applicator is intended to be used with the Acculis MTA System for intra-operative coagulation of soft tissue.Microwave System: Treat lesions using microwave hyperthermia The Avecure Microwave ablation system sponsored by Aurora BioScience Pty Ltd comprises of a microwave generator and disposable probes (that are supplied in two gauges, three antenna lengths and three antenna sizes). The system is designed to produce and control the delivery of high heat to the body (i.e. temperatures greater than 43°C) using microwave energy for the ablation/coagulation of soft tissue. Using temperature feedback, power feedback and an automatic tissue matching-frequency controller the generator controls the ablation process whilst the probes apply the microwave energy into the surrounding local area.Trolley: 191102Microwave System: 200325TGA-approved indication(s) or purpose(s): Trolley: A cart designed for transporting/storing medical equipment and supplies within a hospital/institutional.Microwave System: The system is designed to produce and control the delivery of high heat to the body (i.e. temperatures greater than 43°C) using microwave energy for the ablation/coagulation of soft tissue.The Emprint? Ablation System with Thermosphere? Technology sponsored by Covidien Pty Ltd involves antennas in three lengths to accommodate a variety of procedural applications, a generator, integrated cart, cooling pump, footswitch, remote temperature probe and reusable cable.Temperature Probes: 179391Trolley: 127266/178512Generator: 152044Applicator: 178369Microwave System: 226598TGA-approved indication(s) or purpose(s): Temperature Probes: This device along with various other accessories is used to monitor tissue temperature at or near the ablation site.Trolley: A general-purpose trolley to store/transport medical devices and goods within the area of a hospital/healthcare institution.Generator: Intended for the coagulation (ablation) of soft tissue. The generator delivers microwave output to a single antenna for the ablation of soft tissue.Applicator: Intended for use with the microwave generator for the coagulation of soft tissue. This series of antennas work in conjunction with the microwave ablation pump and microwave pump tubing set to provide a cooled shaft suitable for use in percutaneous, laparoscopic and intra-operative ablation procedures.Microwave System: Intended for use in percutaneous, laparoscopic, and intrao-perative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumours. The Evident? Microwave Ablation Generator Sponsored by Covidien Pty Ltd involves multiple surgical antennas, the generator, pump and cart and pump tubing for when used percutaneously.Temperature Probes: 179391Trolley: 127266/178512Generator: 152044Applicator: 178369Microwave System: 178699TGA-approved indication(s) or purpose(s): Temperature Probes: This device along with various other accessories is used to monitor tissue temperature at or near the ablation site.Trolley: A general-purpose trolley to store/transport medical devices and goods within the area of a hospital/healthcare institution.Generator: Intended for the coagulation (ablation) of soft tissue. The generator delivers microwave output to a single antenna for the ablation of soft tissue.Applicator: Intended for use with the microwave generator for the coagulation of soft tissue. This series of antennas work in conjunction with the microwave ablation pump and microwave pump tubing set to provide a cooled shaft suitable for use in percutaneous, laparoscopic and intra-operative ablation procedures.Microwave System: Intended for use in percutaneous, laparoscopic, and intra-operative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumours. The Amica microwave hyperthermia system sponsored by Culpan Medical Pty Ltd involves an electro-medical apparatus (generator) intended for thermoablation treatment of soft tissue pathologies, using microwave energy and/or radiofrequency energy.Temperature Probes: 230566Applicator: 212510Microwave System: 212509 TGA-approved indication(s) or purpose(s): Temperature Probes: Thermocouple temperature sensor lodged in a closed interstitial needle, for percutaneous, intra-operative or laparoscopic use, for intra-tissue thermometric readings during ablation treatments.Applicator: An interstitial microwave applicator for the thermoablation of soft tissues.Microwave System: An electro-medical apparatus (generator) intended for thermoablation treatment of soft tissue pathologies (such as solid tumours or hyperplasia of the liver, kidney, lung, bone, breast, prostate, etc.), using microwave energy and/or radiofrequency energy.Healthcare resourcesQuestions for public fundingNoneTable SEQ Table \* ARABIC 18List of resources to be considered in the economic analysisProvider of resourceSetting in which resource is providedProportion of patients receiving resourceNumber of units of resource per relevant time horizon per patient receiving resourceDisaggregated unit costMBSItemSafety nets*Other government budgetPrivate health insurerPatientTotal costResources provided to identify eligible population Diagnostic imaging (US, CT, CECT, MRI etc.)RadiologistsRadiology clinic or radiology department (hospital)100%55036 (US abdomen), 56407, 56447 (CT abdomen)Liver function testsPathologylaboratoryunknown66515BiopsyHepatologists or radiologistsOut-patient hospital unknown30409Resources provided to deliver proposed intervention (MTA)Machine cost ($50,000)HospitalIn-patient100%NADisposable probe ($2,960)HospitalIn-patient100%NATime to perform procedure (ablation time of 4-6 minutes per lesion, also time for patient positioning, anaesthetic administration)^Interventional radiologist or surgeonRadiology suite or operating theatre100% (split between two services not known)NAImaging (CT or US)Interventional radiologist or surgeonRadiology suite or operating theatre100% (split between two services not known)55036 (US abdomen), 56407, 56447 (CT abdomen)AnaestheticAnaesthetistRadiology suite or operating theatre100%17610- 17625 (initial consult)21922 (anaesthesia management)Resources provided in association with proposed intervention (MTA)AftercareDedicated nursing staffIn-patient100%NAFollow-up imaging (cross-sectional) 3 to 6 weeks post-procedureRadiologist/radiographerRadiology clinic or radiology department100%56407, 56447 (CT abdomen)Resources provided to deliver comparator 1 (RFA)Machine cost ($40,000-$65,000**)HospitalIn-patient (laparoscopic or open). Out-patient (percutaneous)**100%NADisposable probe ($1,700-$2,700)**HospitalIn-patient (laparoscopic or open). Out-patient (percutaneous)**100%NATime to perform ablation (10-20 minutes)Interventional radiologist or surgeonRadiology suite or operating theatre100%^^ 50950 (percutaneous)50952 (open or laparoscopic)Imaging (CT or US)Interventional radiologist or surgeonRadiology suite or operating theatre100%^^55036 (US abdomen), 56407, 56447 (CT abdomen)AnaestheticAnaesthetistRadiology suite or operating theatre100%^^17610- 17625 (initial consult)21922 (anaesthesia management)Resources provided in association with comparator 1 (RFA)AftercareDedicated nursing staffIn-patient (laparoscopic/open) or out-patient (percutaneous)100%NAFollow-up imaging Radiologist/radiographerRadiology clinic or radiology department100%56407, 56447 (CT abdomen)Resources used to manage patients successfully treated with the proposed interventionFollow-up imaging to confirm no tumour recurrenceRadiologist/radiographerRadiology clinic or radiology department100% of patient successfully treatedFollow-up treatment as requiredMultidisciplinary team as requiredDependant on type of treatment requiredFollow-up palliative care as requiredMultidisciplinary team as requiredDependant on type of treatment requiredResources used to manage patients who are unsuccessfully treated with the proposed interventionFollow-up imaging to confirm incomplete ablation of tumour and/or tumour recurrenceRadiologist/radiographerRadiology clinic or radiology department100% of patients unsuccessfully treatedRe-staging of disease and treatment as determined according to current disease statusMultidisciplinary team as requiredDependant on type of treatment required100% of patients unsuccessfully treatedResources used to manage patients successfully treated with comparator 1Follow-up imaging to confirm no tumour recurrenceRadiologist/radiographerRadiology clinic or radiology department100% of patient successfully treatedFollow-up treatment as requiredMultidisciplinary team as requiredDependant on type of treatment requiredFollow-up palliative care as requiredMultidisciplinary team as requiredDependant on type of treatment requiredResources used to manage patients who are unsuccessfully treated with comparator 1Follow-up imaging to confirm incomplete ablation of tumour and/or tumour recurrenceRadiologist/radiographerRadiology clinic or radiology department100% of patients unsuccessfully treatedRe-staging of disease and treatment as determined according to current disease statusMultidisciplinary team as requiredDependant on type of treatment required100% of patients unsuccessfully treatedCECT – contrast enhanced CT. CT= computed tomography. MRI = magnetic resonance imaging. MBS = Medicare Benefits Scheme. MTA = microwave tissue ablation. NA = not applicable. RFA = radiofrequency ablation. 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