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Risk Factors for Post-ESWL and Post-ERCP Pancreatitis

Sponsor
Changhai Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04619511
Collaborator
(none)
714
Enrollment
33
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The study aimed to identify risk factors for post-ERCP pancreatitis(PEP) after ESWL, and the relationship between the occurrence of post-ESWL pancreatitis and PEP.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    714 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Risk Factors for Post-ESWL and Post-ERCP Pancreatitis in Patients With Chronic Pancreatitis
    Actual Study Start Date :
    Oct 31, 2016
    Actual Primary Completion Date :
    Jul 31, 2019
    Actual Study Completion Date :
    Jul 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. post endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis [up to 1 months]

      The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging.

    2. post pancreatic extracorporeal shock wave lithotripsy (ESWL) pancreatitis [up to 1 months]

      The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients diagnosed with chronic pancreatitis and treated with both ESWL and subsequent ERCP
    Exclusion Criteria:

    • Patients with isolated pancreatic tail stone

    • Patients with suspected or established malignancy

    • Patients with pancreatic ascites

    • Patients attending other interventional clinical trials

    • Patients with non-correctable coagulation disorder

    • Patients with pregnancy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Changhai Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhuan Liao, Principal Investigator, Changhai Hospital
    ClinicalTrials.gov Identifier:
    NCT04619511
    Other Study ID Numbers:
    • ESWL&ERCP
    First Posted:
    Nov 6, 2020
    Last Update Posted:
    Nov 6, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatitis
    Pancreatitis, Chronic

    Study Results

    No Results Posted as of Nov 6, 2020