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The Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis

Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06031363
Collaborator
(none)
192
Enrollment
1
Location
3
Arms
14
Anticipated Duration (Months)
13.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Indomethacin Suppository
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Clinical Study on the Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Regular dosage group

Give indomethacin suppository 100mg anal plug immediately after operation.

Drug: Indomethacin Suppository
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.
Other Names:
  • Indomethacin

    		•
    Experimental: Low dosage group

    Give indomethacin suppository 50mg anal plug immediately after operation.

    Drug: Indomethacin Suppository
    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.
    Other Names:
  • Indomethacin

    		•
    Experimental: High dosage group

    Give indomethacin suppository 150mg anal plug immediately after operation.

    Drug: Indomethacin Suppository
    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.
    Other Names:
  • Indomethacin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. serum amylase concentration [before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation]

      blood test

    Secondary Outcome Measures

    1. incidence of post-ERCP pancreatitis [3rd day after operation]

      number of people with PEP in each group / total number of people in each group

    2. incidence of hyperamylaseemia [3rd day after operation]

      number of people with postoperative hyperamylaseemia in each group / total number of people in each group

    3. incidence of indomethacin adverse reaction events [3rd day after operation]

      number of indomethacin-related adverse events in each group / total number of people in each group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • According to the "Chinese ERCP Guidelines (2018 Edition)", patients with various biliary and pancreatic diseases who have indications for ERCP examination and treatment, who are at least 18 years old and have no contraindications, and who can tolerate the examination;

    • Preoperative blood coagulation function, liver and kidney function indicators are in the normal range;

    • The patients agreed to participate in this experiment, signed the informed consent form, and was approved by the hospital ethics committee.

    Exclusion Criteria:

    • Contraindications to indomethacin and other NSAIDs: such as allergy to indomethacin, severe heart failure, active peptic ulcer/bleeding, perioperative period of coronary artery bypass surgery, etc.;

    • There are severe cardiovascular and cerebrovascular diseases, respiratory insufficiency and coagulation dysfunction, etc., and cannot tolerate ERCP examination;

    • Those who have recently used indomethacin and other non-steroidal anti-infective drugs;

    • Pregnant or lactating women.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006

    Sponsors and Collaborators

    • The First Affiliated Hospital of Soochow University

    Investigators

    • Principal Investigator: Rui Li, Dr., The First Affiliated Hospital of Soochow University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rui Li, Chief of the Department of Gastroenterology, The First Affiliated Hospital of Soochow University
    ClinicalTrials.gov Identifier:
    NCT06031363
    Other Study ID Numbers:
    • 2023004
    First Posted:
    Sep 11, 2023
    Last Update Posted:
    Sep 11, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rui Li, Chief of the Department of Gastroenterology, The First Affiliated Hospital of Soochow University
    Indomethacin Suppository
    Post-ERCP Pancreatitis
    Additional relevant MeSH terms:
    Pancreatitis
    Indomethacin

    Study Results

    No Results Posted as of Sep 11, 2023