<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02992652</url>
  </required_header>
  <id_info>
    <org_study_id>937</org_study_id>
    <nct_id>NCT02992652</nct_id>
  </id_info>
  <brief_title>Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis</brief_title>
  <official_title>Role of Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  The investigators evaluated the role of allopurinol in prevention of post-ERCP&#xD;
           pancreatitis.&#xD;
&#xD;
        -  100 Egyptian patients who were candidates for ERCP were included and divided into two&#xD;
           groups. Group 1 (study group) included 50 patients who received two doses of allopurinol&#xD;
           300 mg each, 15 hours and 3 hours before ERCP and Group 2 (control group) included 50&#xD;
           patients who did not receive allopurinol prophylaxis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A diagnosis of procedure-related pancreatitis was based on an increased serum amylase level&#xD;
      greater than three times the upper normal limits, associated with abdominal pain requiring&#xD;
      analgesics and persisting for at least 24 hours after the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosis of procedure-related pancreatitis</measure>
    <time_frame>At least 24 hours after the ERCP</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Endoscopic Retrograde Cholangiopancreatography</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Underwent ERCP without allopurinol prophylaxis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Allopurinol</intervention_name>
    <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)</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were going to be subjected to ERCP due to different causes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with clinically evident acute pancreatitis or hyperamylesemia (≥150 IU/L)&#xD;
             before the procedure.&#xD;
&#xD;
          -  Current or recent use of allopurinol (within the last 48 hours).&#xD;
&#xD;
          -  Hypersensitivity to allopurinol or hydro-soluble contrast solutions.&#xD;
&#xD;
          -  Current use of drugs with a known interaction with allopurinol, including&#xD;
             cyclophosphamide, chlorpropamide, azathioprine, mercaptopurines, or probenecid.&#xD;
&#xD;
          -  NSAIDS intake within a week prior to assessment.&#xD;
&#xD;
          -  Previous endoscopic or surgical sphincterotomy.&#xD;
&#xD;
          -  Those with severe co-morbid conditions.&#xD;
&#xD;
          -  Female patients with a known or suspected pregnancy and/or lactation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Sara Abdelhakam</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Allopurinol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02992652
org study id: 937
nct id: NCT02992652
lead sponsor: 
has dmc: Yes
-  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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Diagnosis of procedure-related pancreatitis
time frame: At least 24 hours after the ERCP
arm group label: Study Group
arm group type: Active Comparator
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 group label: Control Group
arm group type: No Intervention
description: Underwent ERCP without allopurinol prophylaxis
intervention type: Drug
intervention name: Allopurinol
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)
arm group label: Study Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Sara Abdelhakam
investigator title: Assistant Professor
mesh term: Pancreatitis
mesh term: Allopurinol
sharing ipd: No