Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05779436

Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Biliary Stricture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Massachusetts, Worcester, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Liz Lemke

CONTACT

[email protected]

507-284-2511

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 22, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.