Prospective Randomized Study of PTC and EUS-guided Drainage of the Bile Duct

• efficacy [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  decrease of bilirubine > 50%
• feasibility [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
  succes or not of the intervention to obtain bilairy drainage
• biliary drainage duration [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
  time between intervention and drain withdrawal
• quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  QLQ-C30 questionnary at inclusion and at D30

At this time, endoscopic retrograde cholangiopancreatography (ERCP) stay the gold standard method to achieve biliary drainage in case of malignant or benign stricture. When ERCP fail or if the major papilla is not suitable, percutaneous transhepatic biliary drainage (PTBD) is the most commonly used alternative, surgery having higher morbidity and mortality rates, unacceptable especially in palliative situation. Recent developments in interventional endoscopic ultrasonography (EUS) allow new endoluminal approaches to pancreatic-biliary structures, such as cysto-enterostomy or pancreatic-enterostomy. More recently were described the possibility to realize EUS-guided biliary drainage, through the duodenal or the gastric wall. Advantages of the EUS-guided approach are to be realizable even the papilla is not suitable endoscopically (duodenal stricture or post-surgical status) and to allow if necessary extra-tumoral non anatomic drainage (hepaticogastrostomy). This technique is actually an alternative to PTBD. In comparison of the PTBD, EUS-guided route seems to have less morbidity and to avoid external biliary drainage. Indeed, the morbidity rate of the percutaneous biliary drainage and the EUS-guided biliary drainage range respectively from 25 to 35% and from 0 to 23%. However, none study compare prospectively both techniques. Aims of this study are to compare the morbidity rate, feasibility and efficacy of these techniques.

• Device: biliary drainage
  percutaneous transhepatic biliary drainage (PTBD)
  Other Name: biliary drainage
• Device: EUS guided biliary drainage
  endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall
  Other Name: EUS guided biliary drainage

• Active Comparator: Percutaneous Drainage
  Percutaneous Transhepatic Biliary Drainage (PTBD)
  Intervention: Device: biliary drainage
• Experimental: EUS-guided drainage
  endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall
  Intervention: Device: EUS guided biliary drainage

Inclusion Criteria:

• age >= 18
• Karnofsky >= 50%
• biliary stenosis (malignant or benign stricture)with failure of endoscopic retrograde cholangiopancreatography
• signed informed consent

Exclusion Criteria:

• isolated biliary stenosis of right hepatic canal
• percutaneous biliary drainage < 10 days
• laparotomy < 10 days
• contra-indication to the procedure
• pregnant women