Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

Biliary Stricture Clinical Trial

Official title:

Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779436
• Other study ID #: 23-000450
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Stricture
• Cholestasis
• Constriction, Pathologic

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Test characteristics of POC-CNN	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.