Clinical trial NCT06031363: The Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis
Official title: A Clinical Study on the Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatitis
Cholangiopancreatography, Endoscopic Retrograde
Indomethacin
Keywords: Indomethacin Suppository
Post-ERCP Pancreatitis
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: serum amylase concentration
timeFrame: before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation
Secondary outcomes:
measure: incidence of post-ERCP pancreatitis
timeFrame: 3rd day after operation
measure: incidence of hyperamylaseemia
timeFrame: 3rd day after operation
measure: incidence of indomethacin adverse reaction events
timeFrame: 3rd day after operation
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Rui Li, Dr.
role: PRINCIPAL_INVESTIGATOR
References: