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RECRUITING
NCT03713879
PHASE3

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

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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

Interventions

DEVICE

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)

DRUG

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