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Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Primary Purpose

Endoscopic Retrograde Cholangiopancreatography

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Allopurinol
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endoscopic Retrograde Cholangiopancreatography

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who were going to be subjected to ERCP due to different causes

Exclusion Criteria:

  • Patients with clinically evident acute pancreatitis or hyperamylesemia (≥150 IU/L) before the procedure.
  • Current or recent use of allopurinol (within the last 48 hours).
  • Hypersensitivity to allopurinol or hydro-soluble contrast solutions.
  • Current use of drugs with a known interaction with allopurinol, including cyclophosphamide, chlorpropamide, azathioprine, mercaptopurines, or probenecid.
  • NSAIDS intake within a week prior to assessment.
  • Previous endoscopic or surgical sphincterotomy.
  • Those with severe co-morbid conditions.
  • Female patients with a known or suspected pregnancy and/or lactation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Study Group

    Control Group

    Arm Description

    Received 600 mg of allopurinol divided in two oral doses before the procedure (300 mg at 15 hours and 300 mg at 3 hours before ERCP)

    Underwent ERCP without allopurinol prophylaxis

    Outcomes

    Primary Outcome Measures

    Diagnosis of procedure-related pancreatitis

    Secondary Outcome Measures

    Full Information

    First Posted
    December 11, 2016
    Last Updated
    December 13, 2016
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02992652
    Brief Title
    Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
    Official Title
    Role of Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators evaluated the role of allopurinol in prevention of post-ERCP pancreatitis. 100 Egyptian patients who were candidates for ERCP were included and divided into two groups. Group 1 (study group) included 50 patients who received two doses of allopurinol 300 mg each, 15 hours and 3 hours before ERCP and Group 2 (control group) included 50 patients who did not receive allopurinol prophylaxis.
    Detailed Description
    A diagnosis of procedure-related pancreatitis was based on an increased serum amylase level greater than three times the upper normal limits, associated with abdominal pain requiring analgesics and persisting for at least 24 hours after the procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endoscopic Retrograde Cholangiopancreatography

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Group
    Arm Type
    Active Comparator
    Arm Description
    Received 600 mg of allopurinol divided in two oral doses before the procedure (300 mg at 15 hours and 300 mg at 3 hours before ERCP)
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Underwent ERCP without allopurinol prophylaxis
    Intervention Type
    Drug
    Intervention Name(s)
    Allopurinol
    Intervention Description
    600 mg of allopurinol divided in two oral doses before the procedure (300 mg at 15 hours and 300 mg at 3 hours before ERCP)
    Primary Outcome Measure Information:
    Title
    Diagnosis of procedure-related pancreatitis
    Time Frame
    At least 24 hours after the ERCP

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who were going to be subjected to ERCP due to different causes Exclusion Criteria: Patients with clinically evident acute pancreatitis or hyperamylesemia (≥150 IU/L) before the procedure. Current or recent use of allopurinol (within the last 48 hours). Hypersensitivity to allopurinol or hydro-soluble contrast solutions. Current use of drugs with a known interaction with allopurinol, including cyclophosphamide, chlorpropamide, azathioprine, mercaptopurines, or probenecid. NSAIDS intake within a week prior to assessment. Previous endoscopic or surgical sphincterotomy. Those with severe co-morbid conditions. Female patients with a known or suspected pregnancy and/or lactation.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

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