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.
sphincter of Oddi dysfunction
history of PEP, pancreatic instrumentation or sphincterotomy, precut sphincterotomy,
difficult cannulation defined by >5 cannulation attempts
the use of double wire technique in bile duct access
patients intended for pancreatic stenting e.g. those with pancreatic duct strictures, ampullectomy,
without informed consents from patient or next of kin
age <18
pregnant or lactating women
Parallel
pancreatic stenting
Devicea 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
Drugrectally administered indomethacin before or after ERCP
post-ERCP pancreatitis
Percentage of Participants with post ERCP pancreatitis
high severity of post-ERCP pancreatitis
Percentage of Participants with high severity of post-ERCP pancreatitis using the Clavian-Dindo classification (1 / 2 / 3 / 3a / 3b / 4 / 4a/ 4b / 5)
pancreatitis with complications
Percentage of Participants with pancreatitis with complications using Atlanta classification (Mild / Moderate / Severe / Critical )
hospital stay
period of hospitalisation (days)
endoscopic intervention due to PEP
Percentage of Participants with endoscopic intervention due to Post ERCP pancreatitis
radiologic intervention due to PEP
Percentage of Participants with radiologic intervention due to Post ERCP pancreatitis
surgery due to PEP
Percentage of Participants with Surgical intervention due to Post ERCP pancreatitis
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Chinese University of Hong Kong
Lead sponsor
Xijing Hospital
Collaborator
Changhai Hospital
Collaborator
Tianjin Union Medical Center
Collaborator
Zhejiang University
Collaborator
Eastern Hepatobiliary Surgery Hospital
Collaborator
