RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, …



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

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SYNOPSIS

OF

DISSERTATION

“ROLE OF ULTRASONOGRAPHY AND CT IN DIAGNOSING DIFFERENT TYPES OF ADNEXAL MASSES AND CORRELATION WITH HISTOPATHOLOGICAL REPORT”

Submitted by

Dr. SHAMA. M. SHETTY

M.B.B.S.

POST GRADUATE STUDENT IN

RADIO DIAGNOSIS (M.D.)

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DEPARTMENT OF RADIODIAGNOSIS

ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,

B.G.NAGARA-571448

2013

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

| | | |

|1 |NAME OF THE CANDIDATE |Dr. SHAMA. M. SHETTY |

| |AND ADDRESS |P.G IN RADIODIAGNOSIS, |

| |(in block letters) |ADICHUNCHUNAGIRI INSTITUTE OF |

| | |MEDICAL SCIENCES, B.G NAGARA, |

| | |MANDYA DISTRICT -571448 |

|2. |NAME OF THE INSTITUTION |ADICHUNCHANAGIRI INSTITUTE OF |

| | |MEDICAL SCIENCES, B.G.NAGARA. |

|3. |COURSE OF STUDY AND SUBJECT |M.D. IN RADIO DIAGNOSIS |

|4. |DATE OF ADMISSION TO COURSE |14/06/2013 |

| | |“ROLE OF ULTRASONOGRAPHY AND CT IN DIAGNOSING DIFFERENT TYPES OF |

|5. |TITLE OF THE TOPIC |ADNEXAL MASSES AND CORRELATION WITH HISTOPATHOLOGICAL REPORT” |

|6. |BRIEF RESUME OF INTENDED WORK |APPENDIX - I |

| |NEED FOR THE STUDY |APPENDIX - IA |

| |6.2 REVIEW OF LITERATURE |APPENDIX - IB |

| |6.3 OBJECTIVES OF THE STUDY |APPENDIX - IC |

| |6.4 INCLUSION AND EXCLUSION |APPENDIX – ID |

| |CRITERIA | |

|7 |MATERIALS AND METHODS |APPENDIX - II |

| | | |

| |SOURCE OF DATA |APPENDIX - IIA |

| | | |

| |7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING PROCEDURE | |

| |IF ANY) |APPENDIX - IIB |

| | | |

| |7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO | |

| |BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE | |

| |BRIEFLY. |YES |

| | |APPENDIX - IIC |

| |7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN | |

| |CASE OF 7.3 | |

| | | |

| | |YES |

| | |APPENDIX – IID |

|8. |LIST OF REFERENCES | APPENDIX – III |

| | | |

|9. |SIGNATURE OF THE CANDIDATE | |

| | |Correlation of ultrasonography and CT findings of adnexal masses with|

|10. |REMARKS OF THE GUIDE |that of histopathological findings which will help in |

| | |medical/surgical/non-invasive management. |

|11 |NAME AND DESIGNATION | |

| |(in Block Letters) | |

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| |11.1 GUIDE |Dr. B. MALLIKARJUNAPPA, M.B.B.S, M.D |

| | |PROFESSOR AND HOD, |

| | |DEPARTMENT OF RADIODIAGNOSIS |

| | |A.I.M.S., B.G.NAGARA-571448 |

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| |11.2 SIGNATURE OF THE GUIDE | |

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| |11.3 HEAD OF DEPARTMENT |Dr. B. MALLIKARJUNAPPA, M.B.B.S, M.D |

| | |PROFESSOR AND HOD, |

| | |DEPARTMENT OF RADIODIAGNOSIS |

| | |A.I.M.S., B.G.NAGARA-571448 |

| | | |

| |11.4 SIGNATURE | |

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|12 |12.1 REMARKS OF THE CHAIRMAN |The facilities required for the investigation will be made available |

| |AND PRINCIPAL |by the college |

| | | |

| | |Dr. M.G SHIVARAMU M.B.B.S., MD |

| | |PRINCIPAL, |

| | |AIMS, B.G. NAGARA. |

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| |12.2 SIGNATURE | |

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APPENDIX-I

6.0 BRIEF RESUME OF THE INTENDED WORK:

APPENDIX –I A

6.1 NEED FOR THE STUDY:

Adnexal mass lesions are common among women of all age groups and very common among the reproductive age group. Adnexal masses are quite common presentation of a gynaecological pathology. These adnexal masses can vary from benign masses like functional cysts to malignant masses like ovarian cancer. Fortunately the benign lesions far outnumber the malignant ones. When the benign lesions are clinically insignificant or asymptomatic they can be followed up with USG or even ignored. Symptomatic benign lesions may require simple procedures whereas malignant lesions will require radical surgery.

Adnexal masses pose a special dilemma to the attending gynaecologist because the differential diagnosis is often difficult and complex. Also the nature of the adnexal mass needs to be ascertained, whether benign or malignant, so that the patient gets the appropriate treatment for the condition.

Determining the benign nature of the mass through imaging will not only save the patient from unnecessary surgery but also alleviate patients worry. On the other hand malignant masses need to be identified as early as possible so that the patient gets the appropriate treatment.

Adnexal masses are usually identified either through clinical examination or through USG examination of the pelvis for symptoms caused by the mass or incidentally.

USG is typically the first study to be requested in patients with clinical findings that may suggest pelvic disease. Evaluation of adnexal masses is a common component of a sonologist’s workload. The advantages of USG being its wide availability, decreased costs, safety and simplicity of the examination. USG has been shown to be accurate for both detecting and characterizing adnexal mass. Given the above mentioned advantages USG is the modality of choice for imaging suspected adnexal masses. However, the shortcomings with this modality includes limited field of view, obscuration of pelvic organs by the presence of bowel gas, inherent limitation dependant on patient size and its dependence on the skill and experience of the operator.

CT is the most commonly used primary imaging study for evaluating the extent of adnexal malignancies and for detecting persistent and recurrent tumours. Advantages of CT include oral and rectal contrast opacification of gastrointestinal tract, intravenous contrast enhancement of blood vessels and viscera, fast data acquisition and high spatial resolution. CT of abdomen and pelvis can depict masses as well as probable local or regional invasion. MDCT makes multiplanar evaluation of pelvic and abdominal structures. The advent of helical and MDCT has made it possible for images to be acquired during arterial, capillary and venous phase of enhancement following contrast medium administration.

APPENDIX –I B

6.2 REVIEW OF LITERATURE

A study conducted by Adel El-Badrawy concluded that 64 Multidetector CT allows good visualization and characterization of bilateral ovarian masses with greater diagnostic accuracy and improves the detection of peritoneal metastases1.

A study conducted by Mubarak F concluded that MDCT imaging offers a safe, accurate and non invasive modality to differentiate between benign and malignant ovarian masses and the CT findings used to diagnose malignancy were: diameter greater than 4 cm, cystic-solid mass, necrosis in a solid lesion, cystic lesion with thick, irregular walls or septa, and/or with papillary projections. The presence of ascites, peritoneal metastases, and lymphadenopathy was also used to confirm malignancy2.

A study done by Fatemeh Gatreh-Samani concluded that MDCT is a highly sensitive and specific diagnostic method in evaluation of adnexal masses and successfully stage the tumor in consistent with surgery and histopathology3.

A study conducted by Douglas L Brown et al concluded that pelvic Ultrasonography (US) remains the imaging modality most frequently used to detect and characterize adnexal masses. Although evaluation is often aimed at distinguishing benign from malignant masses, the majority of adnexal masses are benign. About 90% of adnexal masses can be adequately characterized with US alone4.

A study done by Alexader et al concluded that although the sonographic features of a pelvic mass frequently do not permit a specific histopathologic diagnosis, Sonography usually provides clinically important parameters for the evaluation of a pelvic mass. Pelvic Sonography can confirm the presence or absence of a suspected pelvic mass. Sonographic features such as size, consistency, shape, probable origin and relationship of the mass to the other pelvic structures can be valuable parameters in a decision making process. A pelvic mass may be gynecologic in origin or it may arise from the urinary tract or bowel. With the respect to gynecologic causes, lesion can be uterine or adnexal, predominantly ovarian.5

A study done by Zhang J concluded that the features most predictive of malignancy were heterogeneity for a solid lesion, multilocularity (>3 locules), irregular and thickened cystic septations or walls, and the presence of internal vegetations for a cystic lesion. Irregular lesion contour and ancillary findings, including ascites, peritoneal implants, lymphadenopathy, and pleural effusion, were predictive of malignancy in both solid and cystic lesions. Contrast-enhanced helical CT is highly accurate in characterizing adnexal masses as malignant.6

A study conducted by A C Tsili and C Tsampoulas concluded that the MDCT findings that found more predictive of malignancy were the presence of papillary projections in a cystic lesion, necrosis in solid mass and peritoneal metastases and multidetector computed tomography on a 16-row CT scanner proved accurate in the detection and characterization of adnexal masses7.

A study conducted by Mukund Joshi et al concluded that the use of gray-scale ultrasound morphology to characterize a pelvic mass may also be called “pattern recognition”. Subjective evaluation of ovarian masses based on pattern recognition can achieve sensitivity of 88 to 100% and specifically of 62 to 96%8.

Van Calster and others have mentioned that pattern recognition was superior to serum CA – 125 for discrimination between benign and malignant adnexal masses9.

A study conducted by Yong Yeon Jeong concluded that Endovaginal ultrasonography (US) is the most practical modality for assessment of ovarian tumors because it is readily available and has a high negative predictive value. Morphologic analysis of adnexal masses is accurate for identifying masses as either low risk or high risk. The most important morphologic features are non-fatty solid (vascularized) tissue, thick septations, and papillary projections. Color Doppler US helps identify solid, vascularized components in a mass. Spectral Doppler waveform characteristics (eg, resistive index, pulsatility index) correlate well with malignancy but generally add little information to morphologic considerations. Computed tomography can help assess the extent of disease in patients before and after primary cytoreductive surgery10.

APPENDIX –IC

6.3 AIMS AND OBJECTIVES OF STUDY

This study was conducted in order to

1. Ultrasound and CT evaluation of adnexal masses presenting to our hospital.

2. Followed by histopathological correlation

3. Analysis of results using appropriate statistical methods.

4. Assessment of relative sensitivity of ultrasound and CT –imaging modalities of diagnosis of adnexal masses and reliable characterisation of lesions, thus allowing differentiation of malignant from benign lesions.

APPENDIX-ID

6.4 INCLUSION AND EXCLUSION CRITERIA

INCLUSION CRITERIA

• Patients with clinically suspected adnexal masses.

• Patients with adnexal masses which are incidentally detected by ultrasound.

• Patients aged between 14 to 70 yrs.

EXCLUSION CRITERIA:

• Pregnant women

Any absolute contraindication for CT

APPENDIX-II

7.0 MATERIALS AND METHODS

APPENDIX-II A

7.1 SOURCE OF DATA

The data for the study will be collected from outpatients and inpatients referred for ultrasound and CT scan to the Department of Radiodiagnosis, Sri Adichunchanagiri Hospital and Research Centre, B .G. Nagara, Nagamangala Taluk, Mandya District.

Study Design : Prospective study

Study Area : Sri Adichunchanagiri Hospital and Research Centre, B. G. Nagara.

Statistical Analysis : Sensitivity, Specificity and Positive Predictive value will be analysed.

Study Period : January 2014 to August 2015 (18 months).

APPENDIX-II B

1. METHOD OF COLLECTION OF DATA

My intended study is a descriptive study for a period of 18 months. The population consists of patients referred from the in patient ward as well as out patients for evaluation of suspected adnexal masses.

EQUIPMENT:

• Ultrasound with colour Doppler VOLUSON S6 PRO

• Ultrasound with colour Doppler SIEMENS ACUSON X 300

• GE machine 16 SLICE CT BRIVO 385

IMAGING PROTOCOL – Plain and post-contrast dual phase study of the abdomen and pelvis will be done. Bowel opacification is achieved orally with 1000ml of diluted contrast for differentiating fluid filled bowel loops, cystic adnexal tumors and tuboovarian abscess and also improves identification of hydrosalpinx, pyosalpinx. It consists of acquisition of contiguous axial sections, of thickness 5 mm of abdomen and pelvis in cranio-caudal direction from the level of the xiphisternum to pubic-symphysis before and after administration of iodinated intravenous contrast. IV contrast opacification is achieved with 100-120 ml of non ionic contrast media (0.9ml/kg body wt) by infusing at the rate of 3ml/sec. Dual phase study will be done with arterial phase at 20-40sec and venous phase at 70-90 sec. Reconstruction will be done with a slice thickness of 1.25 mm. All images will be viewed in a range of soft tissue window settings.

APPENDIX-II C

7.3 Does the study require any investigation or intervention to be conducted on the patients or animals, if so please describe briefly

Yes, Study requires Ultrasonography and CT

APPENDIX-IID

7.4 Has the ethical clearance been obtained from your institution in case of 7.3?

YES, The certificate of the same has been enclosed.

APPENDIX-IID

PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

| |SECTION A | |

|a |Title of the study |“ROLE OF ULTRASONOGRAPHY AND CT IN DIAGNOSING DIFFERENT TYPES OF ADNEXAL |

| | |MASSES AND CORRELATION WITH HISTOPATHOLOGICAL REPORT” |

|b |Principle investigator | |

| |(Name and Designation) |Dr. SHAMA. M. SHETTY |

| | |P.G IN RADIODIAGNOSIS, |

| | |ADICHUNCHUNAGIRI INSTITUTE OF |

| | |MEDICAL SCIENCES, B.G NAGARA, |

| | |MANDYA DISTRICT -571448 |

|c |Co-investigator | |

| |(Name and Designation) |Dr. B. MALLIKARJUNAPPA, M.B.B.S, M.D |

| | |PROFESSOR AND HOD, |

| | |DEPARTMENT OF RADIODIAGNOSIS |

| | |A.I.M.S., B.G.NAGARA-571448 |

|d |Name of the Collaborating |DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY |

| |Department/Institutions | |

|e |Whether permission has been obtained from the heads of the |YES |

| |collaborating departments & Institution | |

| |Section – B |- |

| |Summary of the Project | |

| |Section – C |APPENDIX – I |

| |Objectives of the study | |

| |Section – D |APPENDIX – II |

| |Methodology | |

|A |Where the proposed study will be undertaken |S.A.H. & R.C., B.G.NAGARA |

|B |Duration of the Project |18 MONTHS |

|C |Nature of the subjects: | |

| |Does the study involve adult patients? |YES |

| |Does the study involve Children? |YES |

| |Does the study involve normal volunteers? |NO |

| |Does the study involve Psychiatric patients? |NO |

| |Does the study involve pregnant women? |NO |

|D |If the study involves health volunteers | |

| |Will they be institute students? |NO |

| |Will they be institute employees? |NO |

| |Will they be Paid? |NA |

| |If they are to be paid, how much per session? |NA |

|E |Is the study a part of multi central trial? |NO |

|F |If yes, who is the coordinator? | |

| |(Name and Designation) |NA |

| | | |

| |Has the trail been approved by the ethics Committee of the other |NA |

| |centers? | |

| | | |

| |If the study involves the use of drugs please indicate whether. |NA |

| | | |

| |I. The drug is marketed in India for the indication in which it will | |

| |be used in the study. |NA |

| | | |

| |II. The drug is marketed in India but not for the indication in | |

| |which it will be used in the study | |

| | |NA |

| |III. The drug is only used for experimental use in humans. | |

| | | |

| |IV. Clearance of the drugs controller of India has been obtained for:| |

| | |NA |

| | | |

| |Use of the drug in healthy volunteers | |

| |Use of the drug in-patients for a new indication. |NA |

| |Phase one and two clinical trials | |

| |Experimental use in-patients and healthy volunteers. | |

| | | |

| | |NA |

|G |How do you propose to obtain the drug to be used in the study? |NA |

| |Gift from a drug company | |

| |Hospital supplies | |

| |Patients will be asked to purchase | |

| |Other sources (Explain) | |

|H |Funding (If any) for the project please state |NONE |

| |None | |

| |Amount | |

| |Source | |

| |To whom payable | |

|I |Does any agency have a vested interest in the out come of the Project? |NO |

|J |Will data relating to subjects /controls be stored in a computer? |YES |

|K | Will the data analysis be done by | |

| |The researcher? |YES |

| |The funding agent |NO |

|L |Will technical / nursing help be required form the staff of hospital. | |

| | |NO |

| |If yes, will it interfere with their duties? | |

| | |NO |

| |Will you recruit other staff for the duration of the study? | |

| | |NO |

| |If Yes give details of | |

| |Designation | |

| |Qualification | |

| |Number | |

| |Duration of Employment |NA |

|M |Will informed consent be taken? If yes |YES, INFORMED CONSENT WILL BE TAKEN FROM THE PATIENT |

| |Will it be written informed consent: | |

| |Will it be oral consent? Will it be| |

| |taken from the subject themselves? | |

| |Will it be from the legal guardian? If no, give reason: | |

|N |Describe design, Methodology and techniques |APPENDIX - II |

Ethical clearance has been accorded.

Chairman,

P.G Training Cum-Research Institute,

A.I.M.S., B.G.Nagara.

Date:

PS: NA – Not Applicable

APPENDIX-III

8. LIST OF REFERENCES

1. Adel El-Badrawy, Eman Omran, Ashraf Khater, Mohamed Awad, Adel Helal. 64 Multidetector CT with multiplanar reformation in evaluation of bilateral ovarian masses. The Egyptian Journal of Radiology and Nuclear Medicine. 2012; 43: 285-91.

2. Mubarak F, Alam MS, Akhtar W, Hafeez S, Nizamuddin N. Role of multi detector computed tomography (MDCT) in patients with ovarian masses. Int J Womens Health. 2011; 3: 123-6.

3. Fatemeh Gatreh-Samani, Mohammad Kazem Tarzamni, Elaheh Olad-Sahebmadarek, Ali Dastranj, Aimaz Afrough. Accuracy of 64-multidetector computed tomography in diagnosis of adnexal tumors. Journal of Ovarian Research. 2011; 4: 15.

4. Douglas L. Brown, Kika M. Dudiak, Faye C. Laing. Adnexal Masses: US Characterization and Reporting. Radiology. 2010; 254: 342-54.

5. Aleksander Ljubic, Tatjana Bozanovic, Zoran Vilendecic. Sonographic Evaluation of Benign Pelvic Masses. Donald School Journal of Ultrasound in Obstetrics and Gynecology. 2009; 3: 58-68.

6. Zhang J, Mironov S, Hricak H, Ishill NM, Moskowitz CS, Soslow RA, Chi DS. Characterization of adnexal masses using feature analysis at contrast-enhanced helical computed tomography. J Comput Assist Tomogr. 2008; 32: 533-40.

7. A C Tsili, C Tsampoulas, A Charisiadi, John Kalef-Ezra, V Dousias, E Paraskevaidis, S C Efremidis. Adnexal masses: accuracy of detection and differentiation with multidetector computed tomography. Gynecologic Oncology. 2008; 110: 22-31.

8. Mukund Joshi, Ganesan K, Munshi HH, Ganesan S, Lawande A. Ultrasound of adnexal masses. Seminar Ultrasound CT, MRI. 2008; 29: 72-97.

9. Van Calster B, Timmerman D, Bourne T et al. Discrimination between benign and malignant adnexal masses by specialist ultrasound examination vs serum CA-125. J Natl Cancer Inst. 2007; 99: 1706-14.

10. Yong-Yeon Jeong, MD, Eric K. Outwater, MD, Heoun Keun Kang, MD: Imaging Evaluation of Ovarian Masses. Radiographics. 2000; 20: 1445-70.

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