Randomized study of precut sphincterotomy versus Endoscopic ultrasonography guided rendezvous technique (EUS-RV) among patients with failed cannulation for distal biliary malignancy during endoscopic retrograde cholangiopancreaticography

Difficult biliary access is defined as the inability to achieve selective biliary cannulation by standard ERCP techniques within 10 minutes or up to 5 cannulation attempts, or failure of access to the major papilla. The endoscopic approach to the ampulla followed by selective deep biliary cannulation is the first step before further therapy. In normal anatomy, about 11% of therapeutic ERCPs may be considered difficult biliary cannulation. Biliary access in patients with surgically altered anatomy, such as Billroth II or Roux-en-Y anastomosis, is considered difficult because special instruments and maneuvers are often needed. Various methods are used to overcome difficult biliary access such as double guide wire-induced cannulation, precut papillotomy, or transpancreatic sphincterotomy with or without placement of a pancreatic stent. These have been used to improve cannulation success rates and have shown good clinical results. But these techniques and procedures are more complex and carry significant risks, requiring specific training. Although precut sphincterotomy ensures over 90% success of biliary cannulation, it has been characterized as an independent risk factor for pancreatitis. It is also reported that precut sphincterotomy increases morbidity when performed in patients without dilatation of their biliary tract. Nevertheless, precut sphincterotomy is a good alternative method in the setting of a failed standard cannulation method. We aim to study the outcome of precut sphincterotomy versus Endoscopic ultrasonography guided rendezvous technique (EUS-RV) among patients with distal biliary malignant obstruction who have failed cannulation during endoscopic retrograde cholangiopancreaticography in a randomized manner.