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Recurrent Extrahepatic Bile Duct Stones as a Late Complication of ERCP in Patients With Coexisting Intra- and Extrahepatic Bile Duct Stones

Sponsor
Air Force Military Medical University, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT06041113
Collaborator
(none)
104
Enrollment
1
Location
10
Anticipated Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The management of coexisting intrahepatic bile duct (IBD) and extrahepatic bile duct (EBD) stones is complicated and requires a multidisciplinary approach. The long-term clinical outcomes of patients initially treated with endoscopic retrograde cholangiopancreatography (ERCP) EBD stone extraction remain unclear. Investigators conducted a retrospective study of patients with coexisting IBD and EBD to investigate the long-term impact of ERCP on the incidence of recurrent EBD stones and to identify risk factors of recurrence.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    104 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Recurrent Extrahepatic Bile Duct Stones as a Late Complication of ERCP in Patients With Coexisting Intra- and Extrahepatic Bile Duct Stones：a Long-term Retrospective Cohort Study
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Jul 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. the recurrence rate of EBD stones [up to 2 years]

      Stone recurrence was defined as new EBD stone formation beyond 3 months after complete initial clearance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • non-gastrointestinal tract reconstruction patients with coexisting IBD and EBD stones who underwent ERCP between July 2008 and December 2020 at Xijing Hospital in China
    Exclusion Criteria:

    • patients with benign or malignant EBD strictures

    • sclerosing cholangitis

    • suspected choledochal cysts

    • liver cirrhosis

    • parasitic liver diseases

    • long-term biliary drainage with biliary stents or percutaneous tubes

    • without a definitive IBD stone or with a diagnosis of liver calcification as determined by imaging review

    • medical records or follow-up information was unavailable

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing Hospital of Digestive Diseases Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Air Force Military Medical University, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanglin Pan, Professor, Air Force Military Medical University, China
    ClinicalTrials.gov Identifier:
    NCT06041113
    Other Study ID Numbers:
    • KY20232281-C-1
    First Posted:
    Sep 18, 2023
    Last Update Posted:
    Sep 18, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Choledocholithiasis
    Calculi

    Study Results

    No Results Posted as of Sep 18, 2023