The purpose of the study is to compare two different techniques (pancreatic sphincterotomy (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and the success of cannulation in difficult cannulation. For the study, the difficult cannulation is de-fined as situation when the common bile duct has not been cannulated in five minutes, after five attempts or after two pancreatic guide wire passages or when any of those limits is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The primary end-point is the risk of PEP .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,190
Helsinki University Hospital
Helsinki, Finland
Post ERCP pancreatitis defined by ESGE guidelines published 2014
Acute pancreatitis within 48 hours post ERCP. Post-ERCP pancreatitis (PEP) is defined as the presence of abdominal pain attributable to acute pancreatitis, together with a need for an unplanned hospitalization or an extension of a planned hospitalization by at least 2 days, and a serum /plasma amylase at least 3 times above the upper limit of normal at 24 hours after the procedure.
Time frame: 48 hours
Biliary cannulation success within 15 minutes after randomization
After randomization, timing to get the wire in biliary duct. First assessed the number of procedures succeeded in 15 minutes.
Time frame: 15 minutes
Biliary cannulation success, total number
The total number of successful biliary cannulations after randomization
Time frame: 2 hours
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