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

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ClinicalTrials.gov Identifier: NCT06031363
Recruitment Status : Completed
First Posted : September 11, 2023
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Rui Li, The First Affiliated Hospital of Soochow University

Study Description
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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
Pancreatitis Cholangiopancreatography, Endoscopic Retrograde Indomethacin Drug: Indomethacin Suppository Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual 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 : November 1, 2022
Actual Primary Completion Date : December 6, 2023
Actual Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arms and Interventions
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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 Name: 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 Name: 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 Name: Indomethacin


Outcome Measures
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Primary Outcome Measures :
  1. serum amylase concentration [ Time Frame: 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 [ Time Frame: 3rd day after operation ]
    number of people with PEP in each group / total number of people in each group

  2. incidence of hyperamylaseemia [ Time Frame: 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 [ Time Frame: 3rd day after operation ]
    number of indomethacin-related adverse events in each group / total number of people in each group


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031363


Locations
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China, Jiangsu
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Investigators
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Principal Investigator: Rui Li, Dr. The First Affiliated Hospital of Soochow University
More Information
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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: September 11, 2023    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rui Li, The First Affiliated Hospital of Soochow University:
Indomethacin Suppository
Post-ERCP Pancreatitis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action