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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatitis, Cholangiopancreatography, Endoscopic Retrograde, Indomethacin

Intervention / Treatment
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* Drug: Indomethacin Suppository


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regular dosage group<br>Give indomethacin suppository 100mg anal plug immediately after operation. | Drug: Indomethacin Suppository<br>* 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.<br>* Other names: Indomethacin;|
| Experimental: Low dosage group<br>Give indomethacin suppository 50mg anal plug immediately after operation. | Drug: Indomethacin Suppository<br>* 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.<br>* Other names: Indomethacin;|
| Experimental: High dosage group<br>Give indomethacin suppository 150mg anal plug immediately after operation. | Drug: Indomethacin Suppository<br>* 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.<br>* Other names: Indomethacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum amylase concentration | 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 | number of people with PEP in each group / total number of people in each group | 3rd day after operation | 
| incidence of hyperamylaseemia | 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 | number of indomethacin-related adverse events in each group / total number of people in each group | 3rd day after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indomethacin Suppository, Post-ERCP Pancreatitis