RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,

KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / Name of Candidate
and address (in block letters) / DR. SUSHMA K.
POST GRADUATE STUDENT,
DEPT OF PATHOLOGY, KIMS,
HUBLI-21
2. / Name of the Institution / KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI-580021 ,
KARNATAKA.
3. / Course of Study & Subject / POST – GRADUATE
M.D. PATHOLOGY
4. / Date of Admission to Course / 8 AUGUST 2013
5. / Title of topic / “FINE NEEDLE ASPIRATION CYTOLOGY STUDY OF SALIVARY GLAND LESIONS”
6. / BRIEF RESUME OF THE INTENDED WORK :
6.1 NEED FOR THE STUDY :
Salivary gland lesions account for 2-6.5% of all neoplasms of the head and neck in adults. A wide variety of neoplastic and non -neoplastic lesions originate in the salivary gland and presents as enlarged masses which are usually accessible for FNAC. They are not generally subjected to incisional or needle biopsy techniques because of the risks of fistula formation, or in the case of neoplasm, of tumor implantation. There is no evidence that these complication occur with FNAC. Cytology can provide a distinction between salivary and non salivary lesion, benign and malignant lesion so also specific and non- specific inflammation. Thus it provides decisive direction for therapeutic management of the patient. FNAC is a simple, quick, inexpensive and minimally invasive technique.
6.2.REVIEW OF LITERATURE:
1.  Bopagoda, Williams et al 2012; FNAC on 96 cases of salivary gland lesions, showed 76cases(79.2% )benign,3cases( 3.1%) malignant, 17 cases(17.7%) were deferred. The cyto-histological concordance seen for benign 73cases(96.1%), malignant 3 cases(100%), among 17 deferred cases of FNAC, 11 cases are benign,5 cases malignant,1 case given as deferred on histology., Accuracy-96.2%,sensitivity-50%,specificity-100%,positive and negative predictive value were 100% and 96%.The study emphasizes the need of re-aspirate the solid areas after cyst fluid aspiration,preferably,under image guidance.
2.  Dr.Khandekar M. M. ,Kavatkar A.N.,Patankar SA,Bagwan IB, Puranik SC,Deshmukh SD et al,2006;FNAC on 70 cases of salivary gland lesions,56 cases(80%) neoplastic, 14 cases(20%)non-neoplastic,Of 56 neoplastic,34 were benign,22 were malignant, sensitivity 94.54%,specificity80.95%.The study emphasizes FNAC as a useful test in diagnosing salivary gland lesions.
3.  Rolf J. postema, MD, Mari-Louise f. van Velthusen,MD,PhD, Michiel W. M. Van den Brekel,MD,Phd, Alfons J.M.Balm,MD,Phd, Johannes L.Peterse,MD, et al 2004,FNAC on 1023 patients with salivary gland lesions, exact type specific concordance of malignant diagnosis was achieved in 66(88%) of 75 cases and in 211(95%) 0f 223 benign cases. Of 19 cases of cytological diagnosis “cyst”, 4 proved to be malignant, accuracy of FNAC is 96%, sensitivity 88%, specificity 99% , concluded, cytology is reliable, accurate technique to assess lesions of salivary glands. The cytological diagnosis of “cyst” and “non-neoplastic lesions” should be interpreted with caution.
4.  Vaidya S, Sinha A, Narayan S, Adhikari S, KC Sabira, et al 2011; FNAC on 58 cases, 39 cases(67.24%) neoplastic,19 cases( 32.76%) non-neoplastic, amongst the 39 neoplastic, 30 cases(76.9%) were benign, and 9 cases( 23.1%) were malignant. Histopathology revealed 30cases(81.05%) were benign, 6 cases(18.95%) were malignant. So sensitivity 81%, specificity100%, accuracy was 96.55%. PPV is 100%, NPP- 95.9%.
5.  Dhanalaksmi .M., Lakshmana Rao, L,krishnaswamy, Manohar.U., Gopalakrishna.K.R, Aruna.P. et al 2009; FNAC on 157 cases of salivary gland enlargement,52 cases(35.62%) of non-neoplastic, 94 cases(64.38%) of neoplastic lesions, histopathology correlation done for 80 cases. Accuracy of FNAC was 94.7% for non-neoplastic, 76.8% for benign neoplasm and 100% for malignant neoplasms.
6.3 OBJECTIVES OF STUDY:
1.  Clinicocytological study of various salivary gland lesions.
2.  To evaluate diagnostic Accuracy of FNAC in diagnosis of salivary gland lesions.
3.  To correlate cytologic findings with histopathology whenever possible.
7 / MATERIALS AND METHODS:
7.1 Source of data:
The study is nearly 4 years with Retrospective nearly 1yr 6months (January2012 to july 2013) and Prospective nearly 2yr 6months (August 2013 to November 2015).
1.  Retrospective study-stained cytological, histopathological slides studied,analysed and correlated.
2.  Prospective study-aspiration carried with informed consent, cytology findings studied, correlated, if required USG guided FNAC will be carried out for few selective cases.
7.2 (a) METHOD OF COLLECTION OF DATA:
Retrospective review of preoperative FNAC, comparing with Histopathological diagnosis.
Prospective study, FNAC will be carried with 10 cc syringe ,20-22 G needle ,material stained with wright stain, heamatoxyline and eosine,papaniculau stain. Formaline fixed (10%), surgically resected specimens will be received, processed for H and E, and special stain if required.
INCLUSION CRITERIA:
All patients with salivary gland swellings.
EXCLUSIONCRITERIA:
Patients with head and neck swellings other than salivary gland swellings.
7.2.(b) SAMPLE SIZE
It is a nearly 4 years both retrospective and prospective study ,all cases received during this period satisfying inclusion ,exclusion criteria will be included.
7.2 (c) Parameters for assessment:
1.  Clinical history.
2.  Physical examination
3.  FNAC smear study
4.  Histopathological study
The following statistical tests will be performed
1.  Sensitivity, Specificity
2.  Accuracy, Positive and Negative predictive value
3.  Histological concordance.
7.3  DOES THE STUDY REQUIRE ANY INVESTIGATIONS TO BE CONDUCTED ON PATIENTS OR ANIMALS? SPECIFY. Yes, FNAC is required to be conducted on patients.
7.4. Has ethical clearance been obtained from ethical committee of your institution?
Yes, ethical clearance has been obtained from ethical committee of KIMS, HUBLI.
8. / LIST OF REFERENCES:
1.  Bopagoda T P M ,Williams H, Validity of FNAC in the diagnosis of salivary gland lesions,journal of Diagnostic pathology 2012(7);1:50-58.
2.  Khandekar M.M., Kavatkar A.N., Patankar SA, Bagwan IB, Puranik SC, Deshmukh SD. FNAC of Salivary Gland Lesions With Histopathological Correlation,Indian Journal Of otolaryngology and Head and Neck Surgery 2006; vol.58 , No.3.
3.  Rolf J. Postema MD, Marie-Louise F.van Velthuysen, MD,Phd, Michiel W.M. van den Brekel, MD, Phd, Alfons J. M.Balm, MD, Phd, Johannes L.Peterse,MD. Accuracy of FNAC of Salivary Gland Lesions in Netherland Cancer Institute, published online 20 april 2004 in WileyInterscience, (www.interscience.wiley.com) DOI:10.1002/hed.10393,418-424.
4.  Vaidya S, Sinha A, Narayana S, Adhikari S, KC Sabira., a comparative study of FNAC and Histopathology in salivary gland lesions ,Journal of Pathology of Nepal 2011; vol 1:108-113.
5.  Dhanalakshmi M ,Lakshmana Rao, L, Krishnaswamy, Manohar.U., Gopalakrishna. K. R., Aruna.P., Lakshmana Rao, Fine Needle Aspiration Cytology and Histopathology of salivary gland lesions: A correlative study in a rural teaching hospital. Journal Of Chinese Clinical Medicine, December 2009 ; Volume 4 : number 12 .
9. / Signature of Candidate
10. / Remarks of Guide / “Since FNAC is inexpensive and minimally invasive technique , total number of cases subjected for FNAC is increasing day by day. So there is need to study FNAC of salivary gland lesions”.
11. / Name and Designation of
(In Block Letters)
11.1 Guide / DR. SUNITHA VERNEKAR, MD,
ASSOCIATE PROFESSOR,
DEPT. OF PATHOLOGY,
KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI-580021.
11.2 Signature
11.5 Head of Department / DR. SUJATA.S.GIRIYAN M.D,
PROFESSOR AND HEAD OF DEPARTMENT DEPARTMENT OF PATHOLOGY,
KARNATAKA INSTITUTE OF MEDICAL SCIENCES,
HUBLI-580021.
11.6 Signature
12. / 12.1 Remarks of the Chairman and
Principal / FORWARDED FOR NEEDFUL
12.2 Signature.