To Study the Role of Liquid Based Cytology (LBC) for Diagnosis and Characterization of Biliopancreatic Tumor s Compared With Standard Cytology and On-site Evaluation.

Study Overview
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Brief Summary
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Liquid Based Cytology is a method of preparing samples for examination in cytopathology.Liquid-based cytology (LBC), enables cells to be suspended in a monolayer. LBC makes better cytological assessment possible with improved sensitivity and specificity, since fixation is better and nuclear details are well preserved in the technique. Conventional cytology is gold standard for biliopancreatic malignancy examination. This method is operator depended and have high inter observer variation . On site evaluation increases the sensitivity of conventional cytology but requires the presence of pathologist at the time of sampling . Our study will compare LBC with conventional cytology ,If found to be non inferior will be great help in centre were on site evaluation cannot be carried out . It will further reduce the interobserver variation

Official Title
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To Study the Role of Liquid Based Cytology (LBC) for Diagnosis and Characterization of Biliopancreatic Tumor s Compared With Standard Cytology and On-site Evaluation: A Non-inferiority Trail.

Conditions
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Pancreatobiliary-Type Carcinoma

Intervention / Treatment
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* Diagnostic Test: Liquid based cytology
* Diagnostic Test: Conventional cytology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting patients (or guardian) undergoing EUS guided sampling of suspected pancreato-biliary tumors Exclusion Criteria: Patients on anti-platelet agents(including aspirin). Patients with deranged coagulation parameters, defined by platelet counts <75,000/mm3 and/or INR >1.8

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liquid based cytology<br>.Liquid-based cytology (LBC), enables cells to be suspended in a monolayer. LBC makes better cytological assessment possible with improved sensitivity and specificity, since fixation is better and nuclear details are well preserved in the technique. Preneoplasticand neoplastic cells are not obscured by other cells, such as normal epithelial and inflammatory cells. LBC techniques are currently applied to cytological samples from several tissues or fluids. They include uterine cervix , endometrium, aspirates from breast , thyroid tumors, ascites and pleural effusion, and urine , LBC technology is suggested as an appropriate diagnostic method for metastatic tumors in cerebrospinal fluid . | Diagnostic Test: Liquid based cytology<br>* Liquid based cytology<br>|
| Active Comparator: Conventional cytology<br>It is a gold standard for histopathological diagnosis of pancreatobiliary malignancies till date | Diagnostic Test: Conventional cytology<br>* Conventional cytology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of LBC for diagnosis of Bilio-pancreatic tumors, compared to cytology, on-site evaluation, and cell-block preparation. |  | 0 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of liquid based cytology versus conventional cytology in the diagnosis of tumor with size < 2 cm or > 2 cm |  | 0 day | 
| Comparison of liquid based cytology versus conventional cytology in the diagnosis of tumor with respect to site of tumor (pancreas biliary tract or gall bladder). |  | 0 day |