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

Not Applicable

Completed

• Conditions: Pancreatitis; Cholangiopancreatography, Endoscopic Retrograde; Indomethacin
• Interventions: Drug: Indomethacin Suppository

• Registration Number: NCT06031363
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

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 Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-09-02
• Study First Submitted QC: 2023-09-02
• Study First Posted: 2023-09-11
• Primary Completion: 2023-12-06
• Study Completion: 2024-01-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular dosage group	Indomethacin Suppository	Give indomethacin suppository 100mg anal plug immediately after operation.
Low dosage group	Indomethacin Suppository	Give indomethacin suppository 50mg anal plug immediately after operation.
High dosage group	Indomethacin Suppository	Give indomethacin suppository 150mg anal plug immediately after operation.

Primary Outcome Measures

Name	Time	Method
serum amylase concentration	before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation	blood test

Secondary Outcome Measures

Name	Time	Method
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
incidence of post-ERCP pancreatitis	3rd day after operation	number of people with PEP in each group / total number of people in each group
incidence of hyperamylaseemia	3rd day after operation	number of people with postoperative hyperamylaseemia in each group / total number of people in each group

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China