Clinical Trial

Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis

Recruiting Phase 3
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Summary
Post ERCP pancreatitis (PEP) occurs in 4 to 5% of patients and is associated with significant morbidities and occasional mortalities. The use of rectall administered indomethacin and pancreatic duct stent (PDS) placement have independently been proven to reduce PEP. The comparative effectiveness of the two methods has however not been studied. It is argued that in the context of indomethacin, the placement of a PDS is unnecessary. Advocates for PDS insertion however believe that mechanical decompression of the pancreatic duct is critical in the prevention of pancreatitis. The investigators propose a multi-centre randomised controlled trial to compare the use of rectal indomethacin to PDS insertion in high risk patients in the prevention of PEP.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2018-10-18; most recent amendment 2025-02-10.
Status change: Not Yet Recruiting → Recruiting 2019-05-24
Trial Details
NCT Number NCT03713879
Lead Sponsor Chinese University of Hong Kong
Collaborators: Xijing Hospital, Changhai Hospital, Tianjin Union Medical Center, First Affiliated Hospital of Zhejiang University, Eastern Hepatobiliary Surgery Hospital
Conditions Post ERCP Pancreatitis
Enrollment 1,734 participants
Start Date 2019-03-21
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-12