A Clinical Study on the Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- serum amylase concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Regular dosage group
Give indomethacin suppository 100mg anal plug immediately after operation.
干预措施: Indomethacin Suppository (Drug)
Low dosage group
Give indomethacin suppository 50mg anal plug immediately after operation.
干预措施: Indomethacin Suppository (Drug)
High dosage group
Give indomethacin suppository 150mg anal plug immediately after operation.
干预措施: Indomethacin Suppository (Drug)
结局指标
主要结局
serum amylase concentration
时间窗: before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation
blood test
次要结局
- incidence of post-ERCP pancreatitis(3rd day after operation)
- incidence of indomethacin adverse reaction events(3rd day after operation)
- incidence of hyperamylaseemia(3rd day after operation)
研究者
Rui Li
Chief of the Department of Gastroenterology
The First Affiliated Hospital of Soochow University