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.

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Pancreatobiliary-Type Carcinoma

Treatments: Diagnostic Test: Liquid based cytology; Diagnostic Test: Conventional cytology

Study type: Interventional

Funder types: Other

Identifiers

NCT04022408

ILBS-Biliopancreatic Tumor-01

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Liquid based cytology

Experimental group

Description:

.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 .

Treatment:

Diagnostic Test: Liquid based cytology

Conventional cytology

Active Comparator group

Description:

It is a gold standard for histopathological diagnosis of pancreatobiliary malignancies till date

Treatment:

Diagnostic Test: Conventional cytology