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A Prospective Cohort Study on the Efficacy of Single Use Disposable Elevator Cap (DEC) Duodenoscopy

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05800171
Collaborator
(none)
5,000
Enrollment
22.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this prospective cohort observational study is to compare incidence of cholangitis cause by multidrug resistant pathogens in patient who underwent ERCP.

The main question it aims to answer are:

  • Is the single use disposable elevator cap duodenoscope more effective in preventing cholangitis caused by MDR than fixed cap duodeoscope?

  • Is the single use disposable elevator cap duodenoscope more effective in preventing severe cholangitis than fixed cap duodenoscope?

Participants will undergo and ERCP procedure. Among the patients who recieved the procedure, those who developed cholangitis after procedure will treated with antibiotics after blood culture test. The result of the post procedure cholangitis group's blood culture test and lab data including LFT will be collected. Researches will compare single use disposable elevator cap duodenoscope group and fixed distal cap duodenoscope group to see if there is difference in the incidence of cholangitis caused by MDR pathogens.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Cohort Study on the Efficacy of Single Use Disposable Elevator Cap (DEC) Duodenoscopy
    Anticipated Study Start Date :
    Apr 3, 2023
    Anticipated Primary Completion Date :
    Feb 21, 2024
    Anticipated Study Completion Date :
    Feb 21, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of cholangitis cuased by MDR pathogens [complication with in 2weeks after ERCP]

      percentage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patient who undergone ERCP

    • 19 years age or older

    Exclusion Criteria:

    • Patients who already undergone biliary drainage

    • Patient who already confirmed of multidrug resistant bacterial infection

    • Pregnant women

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05800171
    Other Study ID Numbers:
    • 2301-097-1396
    First Posted:
    Apr 5, 2023
    Last Update Posted:
    Apr 5, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Seoul National University Hospital
    Single use disposable elevator cap duodenoscope, cholangitis
    Additional relevant MeSH terms:
    Cholangitis

    Study Results

    No Results Posted as of Apr 5, 2023