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.

Not Applicable

• Conditions: Pancreatobiliary-Type Carcinoma
• Interventions: Diagnostic Test: Liquid based cytology; Diagnostic Test: Conventional cytology

• Registration Number: NCT04022408
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-08
• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-13
• Study First Posted: 2019-07-17
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liquid based cytology	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 .
Conventional cytology	Conventional cytology	It is a gold standard for histopathological diagnosis of pancreatobiliary malignancies till date

Primary Outcome Measures

Name	Time	Method
Sensitivity of LBC for diagnosis of Bilio-pancreatic tumors, compared to cytology, on-site evaluation, and cell-block preparation.	0 day

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India