Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

Recruiting

• Conditions: Biliary Stricture

• Registration Number: NCT05779436
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-22
• Study Start: 2023-04-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-13
• Last Update Posted: 2024-04-16
• Primary Completion: 2026-03
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
POC-CNN Model AUC	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 Outcome Measures

Name	Time	Method
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.	Sensitivity and Specificity of POC-CNN for the diagnosis of malignant biliary stricture, Sensitivity and Specificity of biliary brushings and biliary biopsies

Trial Locations

Locations (2)

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States