Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage in Advanced Biliary Tract Malignancy That Failed ERCP (PETRUS Study): A Randomized Pilot Study

Background:

Advanced biliary tract malignancy complicated by obstructive jaundice has been traditionally managed by palliative stent placement at ERCP. In 3-12% of patients with advanced disease tumour involvement of the small bowel or peri-ampullary region may preclude the use of ERCP necessitating percutaneous transhepatic biliary drainage (PTBD) or surgery1. However these techniques have been associated with high complication rates and significant morbidity2. PTBD necessitates traversing the parietal and visceral peritoneum causing a potential for a bile leak and bleeding into the peritoneal cavity. This procedure is also associated with significant pain, lengthy hospital stays and an overall reduction in quality of life, and even procedure related mortality. Indeed the Society of Interventional Radiology (SIR) quality improvements guidelines established the procedural risk of severe major complications including sepsis, bleeding and procedural related death at 2.5% and less severe complications including pain and prolonged hospital admissions at 20%.

In recent years various groups have described endoscopic ultrasound guided access of the left system allowing placement of metal or plastic stents either across the distal stricture or deploying the stent in the stomach (hepatico-gastrostomy), with high technical success3. Retrograde cannulation normally performed from the duodenal bulb allows access to the biliary tract above a malignant stricture with the intent to either pass a guide wire through the papilla and then perform a rendezvous procedure, or the placement of a covered metal stent into the stomach (choledochoenterostomy)10. Cannulation of a dilated segment 2 or 3 sectoral duct is also possible from the proximal stomach where the endoscopist performs all procedures in an antegrade fashion5. Currently these procedures are selectively performed in centres by expert endoscopists from mainly tertiary care academic expert centres including in Leuven. Collectively EUS biliary drainage is technically successful in 75-92% of cases, however reports of bile leaking and peritonitis have been described5.

Various obstacles however still exist to extend the general applicability of this technique outside expert centres. Firstly, no randomized control trials exist comparing the safety and efficacy of EUS biliary access to Percutaneous Transhepatic Cholangiography (PTC). Secondly, current endoscopic techniques utilize standard endoscopic accessories not specifically developed to be utilized within the biliary system when advanced through the gastric wall. Thirdly, specific EUS strategies are needed to prevent or reduce complications associated with percutaneous approaches.

Concept and preliminary experimental data