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

Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06031363
• Other study ID #: 2023004
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: January 31, 2024
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Indomethacin
• Pancreatitis

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum amylase concentration	blood test	before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation
Secondary	incidence of post-ERCP pancreatitis	number of people with PEP in each group / total number of people in each group	3rd day after operation
Secondary	incidence of hyperamylaseemia	number of people with postoperative hyperamylaseemia in each group / total number of people in each group	3rd day after operation
Secondary	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