RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
SYNOPSIS FOR REGISTERATION OF SUBJECT FOR DISSERTATION
DR.SHANKAR SNEHIT
PG IN RADIODIAGNOSIS
AL-AMEEN MEDICAL COLLEGE
BIJAPUR
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
And
Address
(In block letters) / DR.SHANKAR SNEHIT
PG IN RADIODIAGNOSIS,
DEPARTMENT OF RADIOLOGY,
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
2. / Name of the Institution / AL-AMEEN MEDICAL COLLEGE,
BIJAPUR, KARNATAKA.
3 / Course of study and subject / M.D. RADIODIAGNOSIS
4 / Date of admission to course / MAY 2010.
5 / Title of the Topic / A STUDY ON PELVIC MASSES IN FEMALE PATIENTS- ULTRASONOGRAPHY AND DOPPLER FINDINGS, AND ITS CLINICAL AND HISTOPATHOLOGICAL CORRELATION WHEREVER NECESSARY.
6 / Brief resume of the intended work:
6.1 Need for the study
6.2 Review of literature
6.3 Objectives of the study / VIDE ANNEXURE – I
VIDE ANNEXURE – II
VIDE ANNEXURE – III
7 / Material and methods
7.1 Source of data
7.2 Method of collection of data( including sampling procedure if any)
7.3 Does the study require any investigations or interventions to be conducted on patients, humans or animals? If so please describe briefly.
7.4 Has ethical clearance been obtained from your institution in case of 7.3.
7.5 Patient’s Consent Form / VIDE ANNEXURE – IV
VIDE ANNEXURE – IV
YES,VIDE ANNEXURE – V
VIDE ANNEXURE – VI
VIDE ANNEXURE – VII
8 / List of References (About 4-6) / VIDE ANNEXURE – VIII
9 / Signature of candidate
10 / Remarks of the guide / TO STUDY VARIOUS PELVIC MASSES AND ASSESS SPECIFICITY, SENSITIVITY OF USG AND DOPPLER FINDINGS IN PELVIC MASSES
11 / Name & Designation(In block letters)
11.1 Guide
11.2 Signature
11.3 Co-Guide
11.4 Signature
11.5 Head of the Department
11.6 Signature / DR.RAMESH V. MANKARE
MD. RADIODIAGNOSIS
PROFESSOR,
DEPARTMENT OF RADIOLOGY,
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
Dr. SUGUNA V.M.D,OBG
PROFESSOR
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
DR.MUNEER AHMED
MD. RADIODIAGNOSIS
PROFESSOR AND HEAD
DEPARTMENT OF RADIOLOGY,
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
12 / 12.1 Remarks of the chairman & Principal
12.2 Signature
ANNEXURE-I
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Pelvic masses are quite common presentation of a gynecological pathology. In clinical practice these are assessed by clinical pelvic examination. Although most of the pelvic masses are benign yet they are associated with significant morbidity and are the commonest indication for surgery.
Sonography usually provides clinically important parameters for the evaluation of pelvic mass. Pelvic sonography can confirm the presence or absence of a suspected pelvic mass.1
The application of imaging techniques in routine gynecological practice has led to an increased detection rate of pelvic masses.
Evaluation of an adnexal mass, either presenting on physical examination, suspected based on clinical history, or identified on routine pelvic sonography, is a common task for the sonologist. While the clinical context is very important, for the vast majority of sonographically identified adnexal masses, the subsequent management of the patient will be highly dependent on the sonologist’s interpretation of the imaging findings.2
Pelvic Ultrasonography differentiates between solid and cystic masses and indicates uterine or adnexal origin. Solid masses of uterine origin are most often leiomyomas and generally do not need further investigation. Ultrasonography and Doppler scan can provide some valuable features in differentiating benign and malignant masses.
The need for the study is to evaluate pelvic mass using Sonographically [Transvaginal and Transabdominal Sonography] and Doppler scan and balance the risk of surgical intervention for a benign versus malignant tumors.
Many pelvic masses are asymptomatic like small simple cyst which resolves spontaneously or by conservative treatment, on the other hand the asymptomatic masses can be early ovarian cancer which requires early immediate attention.
Thus imaging by Ultrasonography and Doppler helps to locate its origin [ovarian, uterine or bowel] the mass size, consistency, internal architecture by scoring system [IOTA Subgroup- scoring system] which will grade the malignant tumors.
ANNEXURE-II
6.2 REVIEW OF LITERATURE:
Ultrasound is defined as the sound above the range of human hearing i.e.Above the frequency of 20,000Hz (normal human hearing frequency range is between 20Hz-20,000Hz). Medical use of ultrasound involves frequencies greater than 3MHz.
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.1
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 alone. In this article, the important US features that should allow one to make a reasonably confident diagnosis in most cases will be discussed.3
In a prospective multicenter study — the International Ovarian Tumor Analysis — 1066 women with a persistent adnexal mass underwent Transvaginal gray-scale and color Doppler ultrasound examinations by an experienced examiner within 120 days of surgery. Pattern recognition was used to classify a mass as benign or malignant. Of these women, 809 also had blood collected preoperatively for measurement of serum CA-125. Various levels of CA-125 were used as cutoffs to classify masses. Results from both assays were then compared with histological findings after surgery. Conclusion arrived is that Pattern recognition was found superior to serum CA-125 for discrimination between benign and malignant adnexal masses.4
The benefit of using scoring systems or mathematical models to estimate the risk of malignancy in adnexal masses was discussed, and the main IOTA logistic regression model and an IOTA scoring system were discussed in detail. Briefly, the IOTA logistic regression model and scoring system were developed using a database of 1066 patients with an adnexal mass. The data in the database had been prospectively collected within the framework of the IOTA multicenter study, including information on more than 40 demographic and ultrasound variables. The logistic regression model included the 12 variables shown in Table1. For the scoring system the masses were categorized into four subgroups based on their ultrasound appearance: (1) unilocular cyst, (2) multilocular cyst, (3) mass with a solid component but no papillary projections, and (4) mass with one or more papillary projections, a papillary projection being defined as a solid structure protruding from the cyst wall and measuring ≥3 mm in height. For each of the four subgroups a scoring system is used to classify the tumor as benign or malignant (Figure 1).5
Table 1 Variables in the main IOTA logistic regression model8
§ Age*§ Personal history of ovarian cancer*
§ Largest diameter of lesion†
§ Largest diameter of largest solid component†
§ Presence of ascites
§ Presence of flow in papillary projection
§ Irregular internal cyst walls
§ Presence of a purely solid tumor
§ Color score‡
§ Presence of acoustic shadows
§ Current hormonal therapy*
§ Pain during examination*
*Information on these variables was provided to all examiners. †Measurements that were available in the written report of the real-time ultrasound examiner were used if the images did not provide information on size. ‡If there were no color Doppler images available, the color score assigned by the real-time ultrasound examiner was used.
Figure 1 IOTA subgroup scoring system. *Information on this variable was provided to all examiners. †Measurements that were available in the written report of the expert who had performed the real-time ultrasound examination were used if the images did not show information on size. ‡If there were no color Doppler images available, the color score assigned by the real-time ultrasound examiner was used. Ascites, fluid outside the pouch of Douglas; Color score, color content of the tumor scan at power Doppler examination (no color, minimal color, moderate amount of color, abundant color); Irregular wall, presence of irregular internal walls in the lesion; Les D Max, largest diameter of the lesion; Nr locules, number of locules (0, 1, 2, 3, 4, 5 to 10, or 10); Nr Pap, number of separate papillary projections (1, 2, 3, or 3); Pap flow, color Doppler signals detected in at least one papillary projection; Shadows, presence of acoustic shadows; Sol D Max, largest diameter of the largest solid component.5
In a retrospective study conducted on 163 women diagnosed as having a solid adnexal mass on B-mode gray-scale ultrasound, conclusion came is that the presence or absence of ascitis or central blood flow may be helpful for discriminating benign from malignant solid adnexal masses.6
In a prospective study conducted on 927 premenopausal women and 377 postmenopausal women operated on at 2 European university hospitals between January 1992 and December 1997, the conclusion came is that the risk for malignancy in cysts containing papillary formations or solid parts was 3 to 6 times higher than that in unilocular echo-free cysts.7
In a prospective international study involving nine European ultrasound centers, 1066 women with a pelvic mass judged to be of adnexal origin underwent Transvaginal Gray Scale and Color Doppler Ultrasound examination by a skilled examiner before surgery. A standardized examination technique and predefined definitions of ultrasound characteristics were used. Conclusion came is that the Papillary projections are characteristic of borderline tumors and stage 1 primary invasive epithelial ovarian cancer. A small proportion of solid tissue at ultrasound examination makes a malignant mass more likely to be a borderline tumor or a stage 1 epithelial ovarian cancer than an advanced ovarian cancer, a metastasis, or a rare type of tumor.8
In a study conducted from 1987 to 2002, 15,106 asymptomatic women at least 50 years old entered the University of Kentucky’s Ovarian Cancer Screening Program and underwent initial Transvaginal Ultrasonography. If the screen revealed abnormalities, Transvaginal Ultrasonography was repeated in 4 to 6 weeks, along with Doppler flow Ultrasonography and CA 125 testing. Conclusion arrived is that the risk of malignancy in unilocular ovarian cystic tumors less than 10 cm in diameter in women 50 years old or older is extremely low. The majority will resolve spontaneously and can be followed conservatively with serial Transvaginal Ultrasonography.9
ANNEXURE-III
6.3 OBJECTIVES OF THE STUDY:
1. To study the Transabdominal and Transvaginal ultrasonographic and Doppler findings of various pelvic masses.
2. To know the sensitivity, specificity and reliability of Ultrasonography and Doppler Findings of pelvic masses.
3. To compare the diagnostic accuracy of preoperative ultrasound with operative findings and pathological diagnosis.
4. To know the sensitivity, specificity and predictive value of Ultrasonography of benign and malignant masses.
ANNEXURE-IV
7. MATERIAL AND METHODS
7.1 SOURCE OF DATA:
The cases will be recruited from Al-Ameen Medical College Hospital, Bijapur and Govt. District Hospital, Bijapur. Patients referred from the Gynecologic Department with following inclusion criteria and who will be volunteering for this study will be selected.
INCLUSION CRITERIA.
1. Female patients [pre pubertal to post menopausal] of all age group presenting with symptoms like pain in abdomen/pelvis, PV bleeding, PV white discharge, urinary and gastrointestinal pressure symptoms and palpable mass.
2. Also asymptomatic patients where pelvic mass detected at time of routine pelvic examination or at the time of Ultrasonography [Transabdominal and Transvaginal Sonography] done for other diagnosis.
EXCLUSION CRITERIA.
1. Women on ovulation induction drugs.
2. Normal Pregnancy.
SAMPLE SIZE:
It’s a one and half year study from January 2011 to July 2012. The total number of subjects will be those attending the gynecologic OPD in this study period with the inclusion criteria.
7.2 METHOD OF COLLECTION OF DATA:
1. Details of the study protocol will be explained to the subjects.
2. Informed consent will be obtained (After clearance from ethical committee).
3. Study of clinical, Transabdominal and Transvaginal Ultrasonography findings of pelvic masses.
A. Clinical Examination Findings of pelvic mass:
B. Transabdominal and Transvaginal Ultrasonography:
Diagnostic ultrasound employs pulsed, high frequency sound waves that are reflected back from body tissues and processed by the ultrasound machine to create characteristic images. Ultrasonic imaging uses frequencies in the range from 1 to 20 MHz.
All the cases will be subjected to Transabdominal Ultrasonography with full bladder technique with 3.5MHz probe and then Transvaginal Sonography with empty bladder technique with 6.5MHz. TAB and TVS will be performed with the use of TOSHIBA Nemio XG Diagnostic Ultrasound System. Observations included size, shape and echo texture of the adnexal masses in sagittal and transverse planes. IOTA scoring system will be applied to differentiate benign and malignant ovarian tumors.
4. Statistical analysis:
A. Results are expressed as mean ± SD and proportions as percentages.
B. Diagnostic validity [specificity and sensitivity] tests were performed to assess the diagnostic value of Ultrasonography and pathological diagnosis.
ANNEXURE-V
7.3 Does the study require any investigations or interventions to be conducted on patients, humans or animals? If so please describe briefly.
YES.
(I) ROUTINE INVESTIGATION
(a) Blood Examination:
(b)Urine Examination:
(II) SPECIAL INVESTIGATION.
(a) CA 125 levels:
NOTE: THERE IS NO ANIMAL EXPERIMENT INVOLVED IN THE STUDY.
ANNEXURE-VI
ETHICAL COMMITTEE
AL-AMEEN MEDICAL COLLEGE, BIJAPUR
The following study entitled “A STUDY ON PELVIC MASSES IN FEMALE PATIENTS- ULTRASONOGRAPHY AND DOPPLER FINDINGS, AND ITS CLINICAL AND HISTOPATHOLOGICAL CORRELATION WHEREVER NECESSARY” by DR.SHANKAR SNEHIT, P.G. student in Department of Radio-Diagnosis belonging to 2010- 2011 batch, has been cleared from ethical committee of this institution for the purpose of dissertation work.
Chairman
Ethical committee
AL-Ameen Medical College, Bijapur