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Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Sponsor: Chinese University of Hong Kong
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.
Official title: Comparative Effectiveness Between Rectally Administered Indomethacin and Pancreatic Stenting in the Prevention of Post Endoscopic Retrograde Cholangio-panceaticography (ERCP) Pancreatitis: a Randomized Trial
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
1734
Start Date
2019-03-21
Completion Date
2026-12-31
Last Updated
2025-02-12
Healthy Volunteers
No
Conditions
Interventions
pancreatic stenting
a PD stent to be inserted during ERCP (a 3 to 5 cm 5Fr single pigtail pancreatic duct stent without inner flap is used, the stent is inserted after deep cannulation of pancreatic duct with a .025" or .035" wire)
Indomethacin
rectally administered indomethacin before or after ERCP
Locations (7)
Endoscopy centre
Xi'an, Shaanxi, China
Eastern Hepatobiliary Surgery Hospital,Endoscopy centre
Shanghai, Shanghai Municipality, China
Endoscopy centre
Shanghai, Shanghai Municipality, China
Endoscopy centre
Tianjin, Tianjin Municipality, China
Endoscopy centre
Hangzhou, Zhejiang, China
Endoscopy Centre, Prince of Wales Hospital
Hong Kong, Hong Kong, Hong Kong
2. Chulalongkorn University and King Chulalongkorn Memorial Hospital
Bangkok, Thailand