Intrahepatic versus extrahepatic approach for endoscopic ultrasound guided rendezvous technique in patients with difficult biliary cannulation: a randomized controlled trial

Endoscopic retrograde cholangiopancreatography (ERCP) is used for the management of biliary obstruction due to benign or malignant biliary diseases. Guide-wire assisted cannulation technique is the primary technique recommended for biliary cannulation. Though there are advances in techniques and advanced endoscopic imaging, still 5%-20% of cases of ERCP succumb to failure in biliary cannulation (inability to achieve deep biliary cannulation). Moreover, difficult biliary cannulation has shown to increase the risk of complications, especially post ERCP pancreatitis (PEP). Various salvage techniques used to manage difficult biliary cannulation are available, wherein endoscopic ultrasound (EUS) guided rendezvous (EUS-RV) technique is a new method. EUS-RV allows access to bile duct under direct endoscopic imaging facilitating subsequent ERCP procedure. One of the advantages of EUS-RV is biliary drainage using multiple routes. The dilated intrahepatic biliary radicals (IHBR) can be accessed from the liver via the distal esophagus or stomach (Intrahepatic) or the common bile duct (CBD) can be punctured from the proximal duodenum (extrahepatic). Various retrospective studies have been published comparing the two different approaches for EUS-RV. A recent literature review on this topic reported lower technical success rate of intrahepatic approach over extrahepatic, with higher complications, procedural time and hospital stay of the former approach. With lack of randomized controlled trials (RCT) on this topic, this study (RCT) has been designed to compare the technical success of intrahepatic versus extrahepatic approach of EUS-RV at the time of index procedure. Moreover, overall complication rates, post procedure pain scoring, procedure time and radiation exposure will also be assessed in the two groups.