Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

April 27, 2026 updated by: Vinay Chandrasekhara, Mayo Clinic
The purpose of this study is to demonstrate the feasibility and validity of a previously developed peroral cholangioscopy (POC) convolutional neural network (CNN) to determine the etiology of biliary strictures when used in real-time.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
    • Minnesota
      • Rochester, Minnesota, United States, 55905

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

No

Sampling Method

Non-Probability Sample

Study Population

Patients with biliary strictures who are undergoing peroral cholangioscopy (POC) during endoscopic retrograde cholangiopancreatography (ERCP) for the evaluation of a biliary strictures will be identified via review of procedure listings at Mayo Clinic Rochester, Minnesota.

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Anticipation that patient may undergo POC during an endoscopic retrograde cholangioscopy
  • Pregnant patients can be included in the study. Use of the POC-CNN does not convey any new risk to the patient nor fetus.
  • Non-English speaking subjects will be included in the study. Consent for the procedure itself is always done with the assistance of an interpreter via telephone or video. Use of the POC-CNN will be discussed with all patients via this interpreter during the procedure consent.

Exclusion Criteria:

  • Age <18 years old
  • No indication that cholangioscopy will be performed during endoscopic retrograde cholangiopancreatography (ERCP)
  • Prisoner

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

Cohorts and Interventions

Group / Cohort
Patients undergoing cholangioscopy for evaluation biliary stricture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POC-CNN Model AUC
Time Frame: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.
Area Under the Curve (AUC) analysis for POC-CNN for classification of malignant biliary stricture
Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test characteristics of POC-CNN
Time Frame: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.
Sensitivity and Specificity of POC-CNN for the diagnosis of malignant biliary stricture, Sensitivity and Specificity of biliary brushings and biliary biopsies
Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.

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

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)

April 1, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-000450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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