Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

NCT05779436 | Recruiting

• 1 other identifier: 23-000450
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• POC-CNN Model AUC

  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 Outcomes (1)

• Test characteristics of POC-CNN

  Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.

Study Arms (1)

Patients undergoing cholangioscopy for evaluation biliary stricture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

University of Massachusetts

Worcester, Massachusetts, 01655, United States

RECRUITING

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Vinay Chandrasekhara, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liz Lemke

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)