Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore s38
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE.
ANNEXURE - II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. NAME OF THE CANDIDATE AND : Dr. ASHWINI.N.S.
ADDRESS POSTGRADUATE IN PATHOLOGY,
DEPARTMENT OF PATHOLOGY,
MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE,
MYSORE – 570 001
2. NAME OF THE INSTITUTION : MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE, MYSORE.
3. COURSE OF STUDY AND : M. D. PATHOLOGY.
Subject
4. DATE OF ADMISSION TO : 31.05.2013
THE COURSE
5. TITLE OF THE TOPIC : “ULTRASONOGRAPHIC GUIDED FINE NEEDLE ASPIRATION CYTOLOGY (FNAC) STUDY OF ABDOMINO-PELVIC MASSES.”
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
Fine Needle Aspiration(FNA) which is used for making a cytologic diagnosis has become an indispensable component of the work-up of many abnormalities. The introduction of modern diagnostic imaging techniques, mainly ultrasonography (USG), has enabled the detection and location of
lesions in sites which are not easily accessible to surgical biopsies, besides offering vast opportunities for fine needle aspiration of the deeper structures. Intra-abdominal masses are an enigma in surgical practice. A documentary evidence of the nature of the pathology before the initiation of therapy and for prognosis is mandatory. In a majority of cases, the diagnosis which is obtained by fine needle aspiration cytology(FNAC) is the substitute for surgical procedures like diagnostic laparotomy . Most of the intra abdominal masses are non-palpable and even if they are palpable, the idea of their size, shape and the extent of the lesion is not possible. Therefore, various imaging modalities like fluoroscopy, Computed tomography (CT) and Ultrasonography (USG) are used as a guide for fine needle aspiration. Ultrasound guided FNA is a rapid, accurate, economical and safe diagnostic procedure in which any structure visualized can be reached quickly and precisely by a fine needle in any desired plane with constant visualization of needle tip during insertion. Ultrasound-guided aspiration is inexpensive, versatile, with use of non ionizing radiation, does not require injection of contrast medium and can be easily repeated when necessary. Thus ultrasound guided FNAC of intra-abdominal masses is a valuable tool in assessment and a pre-operative diagnostic procedure in management of intra-abdominal lesions.
The present study will be undertaken with the aim of evaluating the overall utility of ultrasound guided FNAC in the diagnosis of intra-abdominal lesions.
6.2 REVIEW OF LITERATURE:
· In a study, 245 subjects having intra-abdominal lesions detected clinically/radiologically underwent USG or CT guided FNA. The diagnostic yield was 92.1% in USG guided, 100% in CT guided and 95% in direct aspiration. The mean age was 45.16 years, with M:F ratio of 1:1.3. There were 148(60.3%) malignant, 55(22.4%) benign, 25(10.2%) inflammatory and one (0.6%) suspicious lesion and 16(6.5%) unsatisfactory smears. The liver and the ovary were the most common sites. Adenocarcinomas and hepatocellular carcinomas were the most common malignant lesions. This study showed 94.1% sensitivity, 100% specificity, 100% positive predictive value, 92.3% negative predictive value and 96.5% diagnostic accuracy .It was concluded that intra-abdominal FNA is a simple, economical and a safe procedure with high sensitivity, specificity and diagnostic accuracy and it can be utilized as a pre-operative procedure for the management of intra-abdominal lesions.1
· Accuracy and short-term complications of ultrasound-guided fine needle aspiration of abdominal masses were investigated. Ultrasound-guided fine needle aspiration was done in 102 patients with intra-abdominal masses. The sensitivity in detecting malignancy was 91.7% and the specificity 100%. The negative predictive value was 78.5%, the positive predictive value 100% and the overall accuracy 93.6%. The minor complications rate was 3.9%, with no major complications. It was concluded that FNA of abdominal masses is a safe diagnostic procedure, with high specificity and sensitivity in detecting malignancies. 2
· Hundred patients with clinically or sonologically diagnosed abdomino-pelvic masses were taken up for a study. The diagnostic accuracy rates of USG guided FNAC for benign, malignant and non-neoplastic lesions were
100%, 96% and 94.4% respectively. The overall accuracy rate was 96.3%. It was concluded that USG guided FNAC is a rapid, cost effective , accurate, non-invasive and a safe diagnostic procedure which can be conveniently used in various abdomino-pelvic masses, thereby avoiding unnecessary, expensive and often invasive diagnostic procedures. It is a highly accurate procedure which can be done on an out-patient basis. It can pre-empt a lengthy and an expensive workup in the search for a primary tumour. It has emerged as a reliable method which involves minimal/ no risks and complications. USG guided FNAC, as the first line investigation, is not only useful in the diagnosis of deep seated, inaccessible and space-occupying lesions, but it also helps in choosing the appropriate management.3
· A reterospective study included 53 abdominal and 47 thoracic masses, ultrasound and CT guided FNAC was done at various anatomic sites. The most common malignancy encountered in the abdomen was hepatocellular carcinoma. Non-small cell carcinoma was the most common diagnosis amongst the lung lesions. It was concluded that this method has high sensitivity and specificity in diagnosing deep seated lesions. 4
· In a study, 86 patients having gastrointestinal masses on clinical basis underwent ultrasound guided FNAC. Forty (46.5%) were males and 46(53.5%) females with majority of patients in the third decade in both sexes. Malignant lesions constituted the maximum number of 42 (48.8%) cases, followed by 36(41.8%) cases of benign and inflammatory lesions. The mean age of malignancy was 39.2 years and the average age of tuberculous patients in this study was 25.5 years . They obtained sensitivity of 93.8%, specificity of 100% and diagnostic accuracy of 94%. It was concluded that ultrasound guided FNAC is an effective and useful method which eliminates the need for surgical biopsy and provides sufficient information for initiation of therapy. 5
· Usefulness of ultrasound and computed tomography guidance in fine needle aspiration cytology diagnosis of deep seated thoracic and abdominal masses was studied. In 85 cases of abdominal masses and 35 cases of thoracic masses, ultrasound and CT guided FNAC was done. Aim of this study was to assess the contribution of clinico-imaging evaluation and image-guided FNAC to the management of patients with deep-seated mass lesions. Combined clinical and imaging evaluation for malignancy showed 80% sensitivity and 59% specificity. In conclusion, guided FNAC is a safe and accurate method for the diagnosis of small lesions in the abdomen and in the chest, as clinico-radiological assessment by itself is not sufficient for diagnosis. 6
· A study of 22 patients with colonic lesions identified on ultrasonography, underwent ultrasound guided FNAC. The sensitivity and specificity of FNAC in the diagnosis of colonic carcinoma was 94 and 100 per cent respectively. In conclusion, ultrasonographically-guided FNAC is a valid method for the diagnosis of colonic tumours. 7
6.3 OBJECTIVES OF THE STUDY:
1. To study the cytomorphological features, age and sex distribution of intra-abdominal lesions.
2. To categorize the lesions organwise and as inflammatory, benign and malignant lesions.
7. MATERIALS AND METHODS:
7.1 SOURCE OF DATA:
Observation method of primary source of information technique for Ultrasonographic guided fine needle aspiration to be done on subjects referred to the Department of Pathology with a provisional clinical diagnosis of intra-abdominal mass from KR Hospital, Mysore Medical College and Research Institute, Mysore.
Sample size: With 5% level of significance, effect size 10% and proportion of
of validity of USG guided FNAC 93.8%, using estimation technique, the inflated
sample size is 30 subjects. However 100% enumeration technique(census method but
for greater than 30 subjects) will be adopted for one year duration from Nov 30th
2013 to Nov 30th 2014.
Evaluation copy of statistical software-SPSS 17/Systat will be used for statistical
analysis.
Study design: Prospective study
Statistical techniques: Proportions, Chi square/ t test for proportions, Bars and
and charts will be used for objective 1. Contingency tables, frequencies and
percentages will be used for objective 2.
7.2 METHODS OF COLLECTION OF DATA:
In our present study, ultrasonographic guided fine needle aspiration will be done on subjects
with a provisional clinical or radiological diagnosis of intra-abdominal mass, referred to the
Department of Pathology from K.R.Hospital, Mysore Medical College and Research Institute,
Mysore.
After thorough clinical examination, ultrasonographic examination will be performed and
those found to have an intra-abdominal mass will be subjected to fine needle aspiration cytology
with a 20-22G needle attached to a 10ml syringe for superficial masses and a 9cm, 20-22 G
spinal needle for deep seated masses. Smears prepared will be fixed in Carnoy’s fixative
and 95% ethyl alcohol and subsequently stained with Hematoxylin and eosin (H & E) and
Papanicolaou stains. Special stains will be used when required.
7.3 INCLUSION CRITERIA
All the patients with clinically and or radiologically diagnosed intra-abdominal mass and
referred for fine needle aspiration cytology will be included in the study.
7.4 EXCLUSION CRITERIA
-All patients with bleeding disorders.
-All patients diagnosed with pregnancy.
-All patients with suspected peritonitis.
.
7.5 Does the study require any investigations or interventions to be conducted
on patients or other humans or animals? If so, please describe briefly.
Yes. The study requires ultrasound guided FNAC to be performed on subjects with
intra-abdominal mass. After taking informed consent, ultrasound guided FNAC will be
performed on subjects with intra- abdominal lesions using 20-22G needle under aseptic
precautions.
7.6 Has ethical clearance been obtained from your institution in case of 7.5?
7.7 Duration of study: 18 months . Nov 30th 2013 to May 30th 2015
8. LIST OF REFERENCES:
1. Sidhalingreddy, Sainath K. Andola. Fine Needle Aspiration Cytology of Intra-Abdominal Lesions. Journal of Clinical and Diagnostic Research 2011 June;Vol 5(3): 551-558.
2. Janek Binek, Peter Spieler, Rainer Hfirlimann, Lidia Zoebeli, Bruno Hammer. Ultrasound guided fine-needle aspiration of abdominal masses: Accuracy and short- term complications. European Journal of Ultrasound 1995;Vol 2(3): 199-203.
3. Hemalatha.A.L, Sumana Sindhuram V, Sushma S, Suma J.K, Varna I, Anubha Aditya. Ultrasound Guided Fnac Of Abdominal-Pelvic masses;The Pathologist’s Perspective Journal of Clinical and Diagnostic Research 2013 February;Vol 7(2): 273-277
4. Parajuli S, Tuladhar A, Basnet RB. Ultrasound and computed tomography guided fine needle aspiration cytology in diagnosing intra-abdominal and intra-thoracic lesions. Journal of Pathology of Nepal 2011;Vol 1: 17-21
5. Ahmad SS, Akhtar K, Arif SH, Nasir A, Khalid M, Mansoor T. Ultrasound guided fine needle aspiration biopsy of gastrointestinal masses. Journal of Cytology 2007; 24(4): 173-177.
6. M Sheikh, S Sawhney, P Dey, O AI-Saeed, A Behbehani. Deep-seated thoracic and abdominal masses: Usefulness of ultrasound and computed tomography guidance in fine needle aspiration cytology diagnosis. Australasian Radiology 2000; 44:155–160.
7. A G Heriot, D Kumar, V Thomas, M Young, J Pilcher, A E A Joseph. Ultrasonographically-guided fine-needle aspiration cytology in the diagnosis of colonic lesions. British Journal of Surgery 1998;85: 1713–1715
9. Signature of the Candidate :
(Dr.ASHWINI.N.S)
10. Remarks of the Guide :
11. Name and Designation of
11.1 Guide : Dr. SHASHIDHAR.H.B
ASSOCIATE PROFESSOR,
DEPARTMENT OF PATHOLOGY,
MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE,
MYSORE.
11.2 Signature of Guide :
11.3 Head of the Department : Dr. BHARATHI.M
PROFESSOR AND HEAD ,
DEPARTMENT OF PATHOLOGY,
MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE,
MYSORE.
11.4 Signature of
Head of the Department :
12. Remarks:
12.1 Remarks of the Dean :
and Director
12.2 Signature of the Dean
and Director :
ETHICAL COMMITTEE CLEARANCE
1. TITLE OF THE DISSERTATION : “ULTRASONOGRAPHIC GUIDED FINE NEEDLE ASPIRATION CYTOLOGY(FNAC) STUDY OF ABDOMINO-PELVIC MASSES.”
2. NAME OF THE CANDIDATE : Dr.ASHWINI.N.S
3. SUBJECT : M.D. PATHOLOGY
4. NAME OF THE GUIDE : Dr. SHASHIDHAR.H.B
ASSOCIATE PROFESSOR
DEPARTMENT OF PATHOLOGY,
MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE, MYSORE.
5. APPROVED/NOT APPROVED :
(If not approved, suggestion)
`
MEDICAL SUPERINTENDENT MEDICAL SUPERINTENDENT
K.R. Hospital, Cheluvamba Hospital,
Mysore. Mysore.
PROFESSOR AND HEAD PROFESSOR AND HEAD
Department of Medicine, Department of Surgery,
K.R. Hospital, Mysore. K.R. Hospital, Mysore.
MEDICAL SUPERINTENDENT LAW EXPERT
PKTB Hospital,
Mysore.
THE DEAN AND DIRECTOR
Mysore Medical College and Research Institute,
Mysore.
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