Clinical Trial Summary
Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic procedure
for many bilio-pancreatic diseases, and requires the first crucial step of the successful
deep cannulation of the common bile duct through the Vater's papilla. Difficult biliary
cannulation (DBC) is a well-recognized risk factor for adverse events (AE) and cannulation
failure, which has been reported in about 11% of ERCP regardless of their indication and a
relevant heterogeneity in definition of DBC is present in the available studies. More
recently, DBC during ERCP has been precisely defined by the European Society of
Gastrointestinal Endoscopy (ESGE) as follows: more than 5 contacts with the papilla whilst
attempting to cannulate; more than 5 minutes spent attempting to cannulate after
visualization of the papilla; more than one unintended pancreatic duct cannulation or
opacification (4). To date, the rate of DBC has not been calculated for specific sub-groups
of ERCP indications. In particular, the rate of DBC in the setting of distal malignant
biliary obstruction (DMBO), a frequent indication for ERCP, has not yet been described. DMBO
is generally secondary to pancreatic adenocarcinoma, distal cholangiocarcinoma, ampullary
carcinomas or adenopathy/metastasis from other cancers, and could potentially increase the
complexity of the procedure as the tumor compression or infiltration alter the normal
duodenal/papillary anatomy or determine duodenal rigidity.
In this study, we aimed to investigate the rate of DBC and the outcome of patients undergoing
ERCP for DMBO.
