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.

Pancreatobiliary-Type Carcinoma Clinical Trial

Official title:

"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".

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04022408
• Other study ID #: ILBS-Biliopancreatic Tumor-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: April 2020
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatobiliary-Type Carcinoma

Intervention

Diagnostic Test:
• Liquid based cytology
Liquid based cytology
• Conventional cytology
Conventional cytology

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of LBC for diagnosis of Bilio-pancreatic tumors, compared to cytology, on-site evaluation, and cell-block preparation.		0 day
Secondary	Comparison of liquid based cytology versus conventional cytology in the diagnosis of tumor with size < 2 cm or > 2 cm		0 day
Secondary	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