xml: <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/NCT06031363</url>
    </required_header>
    <id_info>
      <org_study_id>2023004</org_study_id>
      <nct_id>NCT06031363</nct_id>
    </id_info>
    <brief_title>The Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis</brief_title>
    <official_title>A Clinical Study on the Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital of Soochow University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital of Soochow University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a single-center, randomized, single-blind, parallel controlled clinical study&#xD;
        to explore the optimal dose of postoperative indomethacin suppository for the prevention of&#xD;
        post-ERCP pancreatitis. The purpose of this study is to explore the optimal dosage of&#xD;
        indomethacin suppository for PEP prevention, to study the control effect of indomethacin on&#xD;
        hyperamylaseemia, and to further explore the group of patients who benefit most from this&#xD;
        therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-centre, randomized, single-blind, parallel-controlled designed clinical&#xD;
        study to explore the optimal dose of postoperative indomethacin suppository for the&#xD;
        prevention of post-ERCP pancreatitis. The study will enroll 192 patients who undergo ERCP in&#xD;
        the Department of Gastroenterology of the First Affiliated Hospital of Soochow University&#xD;
        from November 2022 to October 2023, and they will be randomly assigned to 3 groups of 64 each&#xD;
        according to the date of surgery and hospitalisation number in a random number list formed by&#xD;
        SPSS software.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>serum amylase concentration</measure>
      <time_frame>before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation</time_frame>
      <description>blood test</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>incidence of post-ERCP pancreatitis</measure>
      <time_frame>3rd day after operation</time_frame>
      <description>number of people with PEP in each group / total number of people in each group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>incidence of hyperamylaseemia</measure>
      <time_frame>3rd day after operation</time_frame>
      <description>number of people with postoperative hyperamylaseemia in each group / total number of people in each group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>incidence of indomethacin adverse reaction events</measure>
      <time_frame>3rd day after operation</time_frame>
      <description>number of indomethacin-related adverse events in each group / total number of people in each group</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">192</enrollment>
    <condition>Pancreatitis</condition>
    <condition>Cholangiopancreatography, Endoscopic Retrograde</condition>
    <condition>Indomethacin</condition>
    <arm_group>
      <arm_group_label>Regular dosage group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Give indomethacin suppository 100mg anal plug immediately after operation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low dosage group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Give indomethacin suppository 50mg anal plug immediately after operation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High dosage group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Give indomethacin suppository 150mg anal plug immediately after operation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Indomethacin Suppository</intervention_name>
      <description>Patients in the regular dose group are given indomethacin suppository 100 mg anal plug immediately after operation, patients in the low dose group are given indomethacin suppository 50 mg anal plug immediately after operation, and patients in the high dose group are given indomethacin suppository 150 mg anal plug immediately after operation.</description>
      <arm_group_label>High dosage group</arm_group_label>
      <arm_group_label>Low dosage group</arm_group_label>
      <arm_group_label>Regular dosage group</arm_group_label>
      <other_name>Indomethacin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  According to the &quot;Chinese ERCP Guidelines (2018 Edition)&quot;, patients with various&#xD;
               biliary and pancreatic diseases who have indications for ERCP examination and&#xD;
               treatment, who are at least 18 years old and have no contraindications, and who can&#xD;
               tolerate the examination;&#xD;
  &#xD;
            -  Preoperative blood coagulation function, liver and kidney function indicators are in&#xD;
               the normal range;&#xD;
  &#xD;
            -  The patients agreed to participate in this experiment, signed the informed consent&#xD;
               form, and was approved by the hospital ethics committee.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindications to indomethacin and other NSAIDs: such as allergy to indomethacin,&#xD;
               severe heart failure, active peptic ulcer/bleeding, perioperative period of coronary&#xD;
               artery bypass surgery, etc.;&#xD;
  &#xD;
            -  There are severe cardiovascular and cerebrovascular diseases, respiratory&#xD;
               insufficiency and coagulation dysfunction, etc., and cannot tolerate ERCP examination;&#xD;
  &#xD;
            -  Those who have recently used indomethacin and other non-steroidal anti-infective&#xD;
               drugs;&#xD;
  &#xD;
            -  Pregnant or lactating women.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rui Li, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital of Soochow University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Haoran Liu</last_name>
      <phone>+86 188 5140 3933</phone>
      <email>lhr_0716@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Soochow University</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <zip>215006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shuangjie Wu</last_name>
        <phone>+86 512 6797 2743</phone>
        <email>sdfyec@163.com</email>
      </contact>
      <investigator>
        <last_name>Rui Li, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Haoran Liu</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yongda Lu</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First Affiliated Hospital of Soochow University</investigator_affiliation>
      <investigator_full_name>Rui Li</investigator_full_name>
      <investigator_title>Chief of the Department of Gastroenterology</investigator_title>
    </responsible_party>
    <keyword>Indomethacin Suppository</keyword>
    <keyword>Post-ERCP Pancreatitis</keyword>
    <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>Indomethacin</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031363
  org study id: 2023004
  nct id: NCT06031363
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a single-center, randomized, single-blind, parallel controlled clinical study
        to explore the optimal dose of postoperative indomethacin suppository for the prevention of
        post-ERCP pancreatitis. The purpose of this study is to explore the optimal dosage of
        indomethacin suppository for PEP prevention, to study the control effect of indomethacin on
        hyperamylaseemia, and to further explore the group of patients who benefit most from this
        therapy.
  This is a single-centre, randomized, single-blind, parallel-controlled designed clinical
        study to explore the optimal dose of postoperative indomethacin suppository for the
        prevention of post-ERCP pancreatitis. The study will enroll 192 patients who undergo ERCP in
        the Department of Gastroenterology of the First Affiliated Hospital of Soochow University
        from November 2022 to October 2023, and they will be randomly assigned to 3 groups of 64 each
        according to the date of surgery and hospitalisation number in a random number list formed by
        SPSS software.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: serum amylase concentration
  time frame: before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation
  description: blood test
  measure: incidence of post-ERCP pancreatitis
  time frame: 3rd day after operation
  description: number of people with PEP in each group / total number of people in each group
  measure: incidence of hyperamylaseemia
  time frame: 3rd day after operation
  description: number of people with postoperative hyperamylaseemia in each group / total number of people in each group
  measure: incidence of indomethacin adverse reaction events
  time frame: 3rd day after operation
  description: number of indomethacin-related adverse events in each group / total number of people in each group
  arm group label: Regular dosage group
  arm group type: Active Comparator
  description: Give indomethacin suppository 100mg anal plug immediately after operation.
  arm group label: Low dosage group
  arm group type: Experimental
  description: Give indomethacin suppository 50mg anal plug immediately after operation.
  arm group label: High dosage group
  arm group type: Experimental
  description: Give indomethacin suppository 150mg anal plug immediately after operation.
  intervention type: Drug
  intervention name: Indomethacin Suppository
  description: Patients in the regular dose group are given indomethacin suppository 100 mg anal plug immediately after operation, patients in the low dose group are given indomethacin suppository 50 mg anal plug immediately after operation, and patients in the high dose group are given indomethacin suppository 150 mg anal plug immediately after operation.
  arm group label: High dosage group
  arm group label: Low dosage group
  arm group label: Regular dosage group
  other name: Indomethacin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rui Li, Dr.
  role: Principal Investigator
  affiliation: The First Affiliated Hospital of Soochow University
  last name: Haoran Liu
  phone: +86 188 5140 3933
  email: lhr_0716@126.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: The First Affiliated Hospital of Soochow University
  investigator full name: Rui Li
  investigator title: Chief of the Department of Gastroenterology
  mesh term: Pancreatitis
  mesh term: Indomethacin