Prospective Evaluation of Biliary Tissue Sampling With ERCP

April 29, 2026 updated by: Vinay Chandrasekhara, Mayo Clinic

The purpose of this study is to assess the safety, outcomes and performance characteristics of multiple biliary sampling techniques including but not limited to: single operator cholangioscopy (SOC) directed biopsies, transpapillary biliary biopsies (TPBx), brushings and bile aspiration for cytology and FISH in patients undergoing ERCP.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

327

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Adults 18 years of age or older who are undergoing ERCP with tissue sampling for an indeterminate biliary stricture will be identified at the time of their scheduled procedure.

Description

Inclusion Criteria:

Adults > 18 years
Diagnosis of indeterminate biliary stricture
Scheduled clinically indicated ERCP procedure

Exclusion Criteria:

• Adults <18 years, Children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance Characteristics Time Frame: 1 year after ERCP procedure	Accuracy, Sensitivity, Specificity for the detection of malignancy with each sampling technique. Accuracy was calculated as [(true positives + true negatives)/ (true positives + true negatives + false positives + false negatives)] x100 and reported as a percentage. Sensitivity was calculated as [true positive/(true positive + false negative)] x100 and reported as a percentage. Specificity was calculated as [true negatives/(true negatives +false positives)] x100 and reported as a percentage.	1 year after ERCP procedure
Number of Adverse Events Time Frame: Within 30 days of ERCP procedure	Adverse events after biliary sampling	Within 30 days of ERCP procedure
Positive and Negative Predictive Value Time Frame: 1 year after ERCP procedure	Positive Predictive Value calculated as number of true positives divided by the sum of true positives and false positives, expressed as a percentage. Negative predictive value calculated as the number of true negatives divided by the sum of true negatives and false negatives, expressed as a percentage.	1 year after ERCP procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Utilization Time Frame: through study completion, an average of 2 years	Number of ERCPs, Radiological studies etc needed before accurate diagnosis	through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

Principal Investigator: Vinay Chandrasekhara, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Mayo Clinic Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

December 18, 2024

Study Completion (Actual)

January 2, 2025

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)