NCT01499537

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

Prospective Randomized Study of PTC and EUS-guided Drainage of the Bile Duct in Patients With Malignant or Post-operative Jaundice After Failure or Impossibility to Perform Endoscopic Retrograde Cholangiography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Jaundice

Interventions

Type	Name	Description
DEVICE	biliary drainage	percutaneous transhepatic biliary drainage (PTBD)
DEVICE	EUS guided biliary drainage	endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall

Timeline

• Start date: 2011-01-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2011-12-26
• Last updated: 2016-05-19

Locations

3 sites across 2 countries: France, Monaco