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

Not Applicable

Terminated

• Conditions: Biliary Tract Neoplasms

• Registration Number: NCT02615210
• Lead Sponsor: Temple University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-09-22
• Study Start: 2015-11
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-26
• Primary Completion: 2017-11
• Study Completion: 2018-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Age greater than or equal to 18 years
• Presence of indeterminate biliary strictures with clinical indications for ERCP. Strictures are considered indeterminate when evaluation including cross-sectional imaging is non-diagnostic. Patients who have previously undergone ERCP with sampling will be included, as well as those who have not previously undergone ERCP.
• Strictures located above the intrapancreatic bile duct
• The Subject's physician determines and ERCP is clinically indicated
• Able to provide informed consent

Exclusion Criteria

• Prior enrollment in the study or another study evaluating biliary strictures
• Presence of extrahepatic malignancy or previously-diagnosed hepatocellular carcinoma
• Pregnancy
• At-risk populations including prisoners and mentally challenged
• Unwilling to provide informed consent
• Medically unfit to undergo ERCP
• History of liver transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings)	72 Hours	Accuracy, sensitivity, and specificity of the three-sample technique (Spy bite, forceps biopsy, brushings) compared to the two-sample technique (forceps biopsy and brushing) in differentiating malignant from benign biliary strictures

Secondary Outcome Measures

Name	Time	Method
Number of patients who receive additional diagnostic studies without receiving a cancer diagnosis	1 year	Patients who receive a repeat ERCP with sampling, cross-sectional imaging, EUS-FNA, IR-guided biopsies, laparoscopy
Endoscopic Satisfaction with SOC-directed biopsy	2 hours	Endoscopist subjective outcomes using a Likert scale 1-5; * Ease of obtaining the biopsies; * Confidence that the biopsy was taken from the target lesion; * Confidence that an adequate sample was obtained from the biopsy; * Clinical impression of malignant disease
Time from procedure to the initiation of treatment (in cases of malignancy)	1 year