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

March 13, 2024 updated by: Rui Li, The First Affiliated Hospital of Soochow University

A Clinical Study on the Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum amylase concentration
Time Frame: before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation
blood test
before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3rd day after operation
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
3rd day after operation
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
3rd day after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

December 6, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

September 2, 2023

First Submitted That Met QC Criteria

September 2, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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