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

Institut Paoli-Calmettes

Status: Completed

Conditions: Jaundice

Treatments: Device: EUS guided biliary drainage; Device: biliary drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT01499537

APHAGE/IPC 2010-002

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Percutaneous Drainage

Active Comparator group

Description:

Percutaneous Transhepatic Biliary Drainage (PTBD)

Treatment:

Device: biliary drainage

EUS-guided drainage

Experimental group

Description:

endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall

Treatment:

Device: EUS guided biliary drainage