An interventional study of Indomethacin Suppository in Pancreatitis, Cholangiopancreatography, Endoscopic Retrograde and Indomethacin, sponsored by The First Affiliated Hospital of Soochow University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Prevention
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.
752 studies on the registry are indexed under Pancreatitis; 180 are open to participants now.
This study's enrollment of 192 is above the median of 80 across 448 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Give indomethacin suppository 100mg anal plug immediately after operation.
Drug: Indomethacin Suppository
Give indomethacin suppository 50mg anal plug immediately after operation.
Drug: Indomethacin Suppository
Give indomethacin suppository 150mg anal plug immediately after operation.
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.
Also known as: Indomethacin
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
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Soochow University