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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorChinese University of Hong Kong

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

1,734 Participants
are divided into 3 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