Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures — SOCABS  

Biliary Tract Neoplasms Clinical Trial

Official title: Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine if cholangioscopically-directed biopsies provide a higher diagnostic yield for malignancy in the setting of indeterminate biliary strictures when compared to standard means of sampling.

Clinical Trial Description

Biliary strictures in the absence of a mass are a clinical challenge, as current accepted means of sampling provide suboptimal accuracy. Both biliary brushings for cytology and fluoroscopically-directed biopsies produce highly-variable results. Endoscopic ultrasound with fine-needle aspiration has also been employed with variable results. An additional modality, using a single-operator cholangioscope during endoscopic retrograde cholangiopancreatography (ERCP) to obtain cholangioscopically-directed biopsies offers promise in increasing the yield of sampling. Initial observational studies have shown an improved diagnostic yield, but the technique has not been tested in a randomized, medical effectiveness study to better characterize its actual clinical impact. We aim to compare the technique of biopsy-on-biopsy derived sampling via single-operator cholangioscopy with standard fluoroscopically-directed biopsies and brushings in a pilot study. We also aim to perform a medical effectiveness study on the early use of single-operator cholangioscopically (SOC) in the evaluation of undiagnosed biliary strictures. ;

Related Conditions & MeSH terms

• Biliary Tract Neoplasms

• NCT number: NCT02615210
• Study type: Interventional
• Source: Temple University
• Status: Terminated
• Phase: N/A
• Start date: November 2015
• Completion date: November 2018