Back to resultsThe Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis
Primary Purpose
Pancreatitis, Cholangiopancreatography, Endoscopic Retrograde, Indomethacin
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Indomethacin Suppository
Sponsored by
About this trial
This is an interventional prevention trial for Pancreatitis focused on measuring Indomethacin Suppository, Post-ERCP Pancreatitis
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.
Sites / Locations
- The First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Regular dosage group
Low dosage group
High dosage group
Arm Description
Give indomethacin suppository 100mg anal plug immediately after operation.
Give indomethacin suppository 50mg anal plug immediately after operation.
Give indomethacin suppository 150mg anal plug immediately after operation.
Outcomes
Primary Outcome Measures
serum amylase concentration
blood test
Secondary Outcome Measures
incidence of post-ERCP pancreatitis
number of people with PEP in each group / total number of people in each group
incidence of hyperamylaseemia
number of people with postoperative hyperamylaseemia in each group / total number of people in each group
incidence of indomethacin adverse reaction events
number of indomethacin-related adverse events in each group / total number of people in each group
Full Information
NCT ID
NCT06031363
First Posted
September 2, 2023
Last Updated
September 2, 2023
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT06031363
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Cholangiopancreatography, Endoscopic Retrograde, Indomethacin
Keywords
Indomethacin Suppository, Post-ERCP Pancreatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Regular dosage group
Arm Type
Active Comparator
Arm Description
Give indomethacin suppository 100mg anal plug immediately after operation.
Arm Title
Low dosage group
Arm Type
Experimental
Arm Description
Give indomethacin suppository 50mg anal plug immediately after operation.
Arm Title
High dosage group
Arm Type
Experimental
Arm Description
Give indomethacin suppository 150mg anal plug immediately after operation.
Intervention Type
Drug
Intervention Name(s)
Indomethacin Suppository
Other Intervention Name(s)
Indomethacin
Intervention Description
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.
Primary Outcome Measure Information:
Title
serum amylase concentration
Description
blood test
Time Frame
before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation
Secondary Outcome Measure Information:
Title
incidence of post-ERCP pancreatitis
Description
number of people with PEP in each group / total number of people in each group
Time Frame
3rd day after operation
Title
incidence of hyperamylaseemia
Description
number of people with postoperative hyperamylaseemia in each group / total number of people in each group
Time Frame
3rd day after operation
Title
incidence of indomethacin adverse reaction events
Description
number of indomethacin-related adverse events in each group / total number of people in each group
Time Frame
3rd day after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haoran Liu
Phone
+86 188 5140 3933
Email
lhr_0716@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Li, Dr.
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuangjie Wu
Phone
+86 512 6797 2743
Email
sdfyec@163.com
First Name & Middle Initial & Last Name & Degree
Rui Li, Dr.
First Name & Middle Initial & Last Name & Degree
Haoran Liu
First Name & Middle Initial & Last Name & Degree
Yongda Lu
12. IPD Sharing Statement
Learn more about this trial
The Optimal Dose of Indomethacin Suppository for Preventing Post-ERCP Pancreatitis
We'll reach out to this number within 24 hrs