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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular dosage group | Active Comparator | Give indomethacin suppository 100mg anal plug immediately after operation. |
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| Low dosage group | Experimental | Give indomethacin suppository 50mg anal plug immediately after operation. |
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| High dosage group | Experimental | Give indomethacin suppository 150mg anal plug immediately after operation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin Suppository | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| serum amylase concentration | blood test | before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of post-ERCP pancreatitis | number of people with PEP in each group / total number of people in each group | 3rd day after operation |
| incidence of hyperamylaseemia | number of people with postoperative hyperamylaseemia in each group / total number of people in each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rui Li, Dr. | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 | 3rd day after operation |