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 Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Liquid based cytology .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
Liquid based cytology
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Active Comparator: Conventional cytology It is a gold standard for histopathological diagnosis of pancreatobiliary malignancies till date |
Diagnostic Test: Conventional cytology
Conventional cytology
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Outcome Measures
Primary Outcome Measures
- Sensitivity of LBC for diagnosis of Bilio-pancreatic tumors, compared to cytology, on-site evaluation, and cell-block preparation. [0 day]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Consenting patients (or guardian) undergoing EUS guided sampling of suspected pancreato-biliary tumors
Exclusion Criteria:
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Patients on anti-platelet agents(including aspirin).
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Patients with deranged coagulation parameters, defined by platelet counts <75,000/mm3 and/or INR >1.8
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Institute of Liver & Biliary Sciences | New Delhi | Delhi | India | 110070 |
Sponsors and Collaborators
- Institute of Liver and Biliary Sciences, India
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ILBS-Biliopancreatic Tumor-01