Recruiting

Cholangioscopy

Sponsor:

Mayo Clinic

Code:

NCT05779436

Conditions

Biliary Stricture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Biliary Stricture

Study ID

NCT05779436

Start date

Apr 1, 2023

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients undergoing cholangioscopy for evaluation biliary stricture

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Liz Lemke

507-284-2511lemke.elizabeth@mayo.edu

Locations

University of Massachusetts

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Neil Marya

(508) 334-3068neil.marya@umassmemorial.org

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Vinay Chandrasekhara, MD

5077742687chandrasekhara.vinay@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-01.