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Prospective Evaluation of Biliary Tissue Sampling With ERCP

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04572711
Collaborator
(none)
500
Enrollment
1
Location
68.9
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, outcomes and performance characteristics of multiple biliary sampling techniques including but not limited to: single operator cholangioscopy (SOC) directed biopsies, transpapillary biliary biopsies (TPBx), brushings and bile aspiration for cytology and FISH in patients undergoing ERCP.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Evaluation of Biliary Tissue Sampling With ERCP
    Actual Study Start Date :
    Sep 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    May 30, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Performance characteristics [1 year after ERCP procedure]

      Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value for the detection of malignancy with each sampling technique

    2. Number of adverse events [Within 30 days of ERCP procedure]

      Adverse events after biliary sampling

    Secondary Outcome Measures

    1. Healthcare Utilization [through study completion, an average of 2 years]

      Number of ERCPs, Radiological studies etc needed before accurate diagnosis

    Eligibility Criteria

    Criteria

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

    • Adults > 18 years

    • Diagnosis of indeterminate biliary stricture

    • Scheduled clinically indicated ERCP procedure

    Exclusion Criteria:

    • Adults <18 years, Children

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester 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:
    NCT04572711
    Other Study ID Numbers:
    • 20-004079
    First Posted:
    Oct 1, 2020
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Nov 1, 2021
    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:
    Cholangiocarcinoma
    Biliary Tract Diseases

    Study Results

    No Results Posted as of Dec 2, 2021