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Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05779436
Collaborator
(none)
100
Enrollment
2
Locations
12
Anticipated Duration (Months)
50
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Mar 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients undergoing cholangioscopy for evaluation biliary stricture

    Outcome Measures

    Primary Outcome Measures

    1. 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

    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.]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 ERCP

    • Prisoner

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Massachusetts Worcester Massachusetts United States 01655
    2 Mayo Clinic Minnesota Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Vinay Chandrasekhara, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Vinay Chandrasekhara, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05779436
    Other Study ID Numbers:
    • 23-000450
    First Posted:
    Mar 22, 2023
    Last Update Posted:
    Mar 22, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cholestasis
    Constriction, Pathologic

    Study Results

    No Results Posted as of Mar 22, 2023