About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- pancreatic stenting
- Indomethacin
Treatment groups
Sponsors and collaborators
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