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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
192
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.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
serum amylase concentration
blood test
Time frame: before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation
incidence of post-ERCP pancreatitis
number of people with PEP in each group / total number of people in each group
Time frame: 3rd day after operation
incidence of hyperamylaseemia
number of people with postoperative hyperamylaseemia in each group / total number of people in each group
Time frame: 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
Time frame: 3rd day after operation
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