Status:

COMPLETED

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

Lead Sponsor:

The First Affiliated Hospital of Soochow University

Conditions:

Pancreatitis

Cholangiopancreatography, Endoscopic Retrograde

Eligibility:

All Genders

18+ years

Phase:

NA

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 pancre...

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 pan...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 31 2024

Estimated Enrollment :

192 Patients enrolled

Trial Details

Trial ID

NCT06031363

Start Date

November 1 2022

End Date

January 31 2024

Last Update

March 15 2024

Active Locations (1)

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The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006