Download RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
SYNOPSIS FOR REGISTERATION OF SUBJECT FOR
DISSERTATION
A STUDY ON PELVIC MASSES IN FEMALE PATIENTSULTRASONOGRAPHY AND DOPPLER FINDINGS, AND
ITS CLINICAL AND HISTOPATHOLOGICAL
CORRELATION WHEREVER NECESSARY
DR.SHANKAR SNEHIT
PG IN RADIODIAGNOSIS
AL-AMEEN MEDICAL COLLEGE
BIJAPUR
1
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
1
Name of the candidate
And
Address
(In block letters)
2.
Name of the Institution
3
4
5
Course of study and subject
Date of admission to course
Title of the Topic
6
Brief resume of the intended
work:
6.1 Need for the study
6.2 Review of literature
6.3 Objectives of the study
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
List of References (About 4-6)
Signature of candidate
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8
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DR.SHANKAR SNEHIT
PG IN RADIODIAGNOSIS,
DEPARTMENT OF RADIOLOGY,
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR, KARNATAKA.
M.D. RADIODIAGNOSIS
MAY 2010.
A STUDY ON PELVIC MASSES IN
FEMALE PATIENTSULTRASONOGRAPHY AND
DOPPLER FINDINGS, AND ITS
CLINICAL AND
HISTOPATHOLOGICAL
CORRELATION WHEREVER
NECESSARY.
2
VIDE ANNEXURE – I
VIDE ANNEXURE – II
VIDE ANNEXURE – III
VIDE ANNEXURE – IV
VIDE ANNEXURE – IV
YES,VIDE ANNEXURE – V
VIDE ANNEXURE – VI
VIDE ANNEXURE – VII
VIDE ANNEXURE – VIII
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Remarks of the guide
11
Name & Designation(In block
letters)
11.1 Guide
TO STUDY VARIOUS PELVIC
MASSES AND ASSESS
SPECIFICITY, SENSITIVITY OF
USG AND DOPPLER FINDINGS
IN PELVIC MASSES
DR.RAMESH V. MANKARE
MD. RADIODIAGNOSIS
PROFESSOR,
DEPARTMENT OF RADIOLOGY,
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
11.2 Signature
11.3 Co-Guide
Dr. SUGUNA V.M.D,OBG
PROFESSOR
DEPARTMENT OF OBSTETRICS
AND GYNECOLOGY
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
11.4 Signature
11.5 Head of the Department
DR.MUNEER AHMED
MD. RADIODIAGNOSIS
PROFESSOR AND HEAD
DEPARTMENT OF RADIOLOGY,
AL-AMEEN MEDICAL COLLEGE,
BIJAPUR
11.6 Signature
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12.1 Remarks of the chairman
& Principal
12.2 Signature
3
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
4
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.
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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
6
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
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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.
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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
9
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
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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.
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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.
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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.
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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.
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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 RadioDiagnosis 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
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ANNEXURE-VII
AL-AMEEN MEDICAL COLLEGE BIJAPUR
CONSENT FORM
Patient’s statement
I voluntarily accept admission to the Department of Radio-Diagnosis for the
performance of the studies. The nature, demands and hazards involved in these studies
have been fully explained to me. I understand that I may withdraw from these studies
at any time for any reason. I confirm that I have passed my eighteenth birthday, the
required minimum age necessary to take part in an adult research study.
I consent to the release of scientific data resulting from my participation in this study
to the Principal Investigator for use by him/her for scientific purposes. The principal
Investigator assures my anonymity. I understand that the record of this experiment
becomes part of my medical record and is protected as a confidential document. I
understand that this record will only be available to physicians and investigators
involved with this study. Other staff may be authorized by the Head to review the
record for administrative purposes or for monitoring the quality of patient care.
In the unlikely event of physical injury resulting from participation in this research, I
understand that medical treatment will be available from the AMC hospital, including
first aid, emergency treatment and follow–up care as needed. However, no
compensation can be provided for medical care apart from the foregoing. I further
understand that making such medical treatment available, or providing it, does not
imply that such injury is the fault of the investigator(s). I also understand that by my
participation in this study I am not waiving any of my legal rights. I understand that in
the case of any problem I can contact Dr.Ramesh V. Mankare, of the Dept of RadioDiagnosis or any member of the Institutional Ethical Review Board, AMC Bijapur.
Date: ---------------------
Signature: --------------------
Witness: -------------------
Name: ----------------------
Physician’s Statement:
I have carefully explained the nature, demands and foreseeable risks of the
above studies to the patient.
Date: --------------------
Signature: --------------------16
ANNEXURE-VIII
8. LIST OF REFERENCES:
1. Aleksander Ljubic, Tatjana Bozanovic, Zoran Vilendecic.
Sonographic
Evaluation of Benign Pelvic Masses. Donald School Journal of Ultrasound in
Obstetrics and Gynecology, April-June 2009;3(2):58-68.
2. Maitray D. Patel, MD. Practical Approach to the Adnexal Mass. Radiol Clin N
Am 44 (2006) 879-899.
3. Douglas L.Brown, Kika M.Dudiak, Faye C.Laing. Adnexal Masses: US
Characterization and Reporting. Radiology: Volume254 : Number 2February2010. 342-354. (radiology.rsna.org).
4. Van Calster B, Timmerman D, Bourne T, et al. Discrimination between
benign and malignant adnexal masses by specialist ultrasound examination
versus serum CA-125. J Natl Cancer Inst 2007;99:1706–1714.
5. C. Van Holsbeke, A. Daemen, J. Yazbek, et al. Ultrasound methods to
distinguish between malignant and benign adnexal masses in the hands of
examiners with different levels of experience. Ultrasound Obstet Gynecol
2009; 34: 454–46.
6. Juan Luis Alcazar, Pedro Royo, Laura Pineda, et al. Which Parameters could
be Usefull for Predicting Malignancy in Solid Adnexal Mass? Donald School
Journal of Ultrasound in Obstetrics and Gynecology, January-March
2009;3(1):1-5.
7. Erling Ekerhovd, Heinrich Wienerroith, et al. Preoperative assessment of
unilocular adnexal cysts by Transvaginal Ultrasonography: A comparison
17
between
Ultrasonographic
morphologic
imaging
and
histopathologic
diagnosis. Am J Obstet Gynecol 2001;184:48-54.
8. Lil Valentin, Lieveke Ameye, Antonia Testa, et al. Ultrasound characteristics
of different types of adnexal malignancies. Gynecologic Oncology 102 (2006)
41–48.
9. Susan C.Modesitt, Edward J.Pavlik, Frederick R.Ueland, et al. Risk of
Malignancy in Unilocular Ovarian Cystic Tumors Less Than 10 Centimeters
in Diameter. Obstet Gynecol 2003;102:594 –599.
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PROFORMA
Case No.:
IP No.:
Name:
Occupation:
Age:
Address:
A. PRESENTING COMPLAINTS:
Lump in abdomen:
Pain abdomen:
Loss of weight / Appetite:
Fever:
Distention of abdomen:
Bowel and bladder disturbances:
Excessive PV bleeding:
PV white discharge:
Others:
B. MENSTRUAL CYCLE:
Cycles: Regular / Irregular
Flow: Moderate / Excessive
Attained menarche:
Reproductive Age group:
Post-Menopausal Period:
C. OBSTETRIC HISTORY:
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D. PAST HISTORY:
1. H/O similar complaints in the past
2. H/O previous surgery.
3. H/O T.B/DM/Hypertension.
E. FAMILY HISTORY:
F. PERSONAL HISTORY:
G. GENERAL PHYSICAL EXAMINATION:
Anemia:
Pulse:
Jaundice:
B.P:
Lymphadenopathy:
Temperature:
H. GYNECOLOGICAL EXAMINATION FINDINGS:
1. Per Speculum Examination:
2. Per Vaginal Examination:
3. Per Rectal Examination:
I. INVESTIGATIONS:
(1) ROUTINE INVESTIGATION:
(a) Blood Examination:
(b) Urine Examination:
(2) SPECIAL INVESTIGATION:
(a) CA 125 levels:
J. RADIOLOGY:
(1) Chest X-ray:
(2) X-Ray abdomen:
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(3) Ultrasonography: [Transabdominal / Transvaginal]
Site:
Size:
Shape:
Echogenicity:
No. of Locules:
Septations:
Wall thickness:
Borders:
Solid elements:
Maximum Diameter of Largest Solid element:
Inner wall structure:
No. of Papillary projections:
Free fluid:
IOTA score:
(4) Color Doppler:
(5) MRI [if done]:
(6) CT Scan [if done]:
K. CLINICAL FOLLOW-UP:
1. Type of operation done:
2. Intra operative Findings:
3. Post op period:
Eventful/uneventful
L. HISTOPATHOLOGY:
1. Gross:
2. Microscopy:
3. Impression:
M. DIAGNOSIS:
1. Clinical diagnosis:
2. Ultrasound diagnosis:
3. Operative diagnosis:
4. Histopathological diagnosis:
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