Status:
UNKNOWN
Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate for PEP Prevention
Lead Sponsor:
Air Force Military Medical University, China
Conditions:
Post-ERCP Acute Pancreatitis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) are at risk for post-ERCP pancreatitis (PEP), which is associated with adverse outcomes. Combination prophylaxis strategies ar...
Eligibility Criteria
Inclusion
- Patients (age, 18-80 y) with native papilla planned for diagnostic or therapeutic ERCP were eligible for enrollment in the study.
Exclusion
- contraindications to ERCP;
- allergy to nitrates or NSAIDs;
- currently on nitrate medication;
- receiving NSAIDs within 7 days;
- not suitable for indomethacin eg, gastrointestinal hemorrhage within the past 4 weeks, renal dysfunction (creatinine level \>1.4 mg/dL) or the presence of coagulopathy before the procedure (international normalized ratio \> 1.5);
- acute pancreatitis within 3 days;
- pregnant or breastfeeding women;
- unwilling or inability to provide consent.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
2700 Patients enrolled
Trial Details
Trial ID
NCT04425993
Start Date
July 1 2020
End Date
December 30 2022
Last Update
October 22 2020
Active Locations (4)
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1
Xiamen Humanity Hospital
Xiamen, Fujian, China
2
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730030
3
Xi'an Central Hospital
Xi'an, Shaanxi, China, 710032
4
Xijing Hoapital
Xi'an, Shaanxi, China, 710032