Difficult biliary cannulation: A randomized trial of early needle knife sphincterotomy.

INTERVENTION: Needle knife sphincterotomy This technique involves cutting through the duodenal mucosa directly into the bile duct rather than directly cannulating the bile duct via the anatomical opening (Ampulla of Vater). It involves the use of a needle knife ‐ a thin stiff wire that cuts through the use of diathermy. Typically the needle knife technique takes between 1 ‐ 10 minutes to gain access. Once used to gain access, it is not used again during the procedure. CONDITION: Biliary cannulation success Post ERCP complications Post ERCP pancreatitis PRIMARY OUTCOME: Post ERCP pancreatitis ; This outcome will be determined by blood tests ‐ amylase and lipase at 24 hours. ; In the event of post procedural pain, clinical assessment will be performed and blood tests may be performed at an earlier timepoint. A CT scan may be performed if acute pancreatitis is confirmed on blood tests and clinical assessment, as this can suggest the severity of the pancreatitis episode. ; Patients will be contacted via phone within the first 5 days and again at day 30. Questions will relate to the symptoms of possible complications. SECONDARY OUTCOME: Biliary cannulation success ; This outcome is assessed at the time of the procedure and confirmed by the use of fluroscopy (XRay) and radio‐opaque contrast and wires that identifies the bile duct and biliary tree. Post ERCP complications (non pancreatitis) ; This outcome is assessed by a combination of clinical assessment, blood tests and imaging. ; Complications typically occur within the first 14 days, predominantly in the first 24 hours. If there is a clinical suspicion of complications apart from pancreatitis ‐ such as perforation or bleeding, the appropriate imaging and blood tests will be performed for confirmation of the diagnosis. INCLUSION CRITERIA: Biliary indication for ERCP Naive biliary sphincter