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

Not Applicable

Completed

• Conditions: Jaundice

• Registration Number: NCT01499537
• Lead Sponsor: Institut Paoli-Calmettes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-09-16
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Morbidity rate	30 days	Morbidity rate during 30 post-operative days

Secondary Outcome Measures

Name	Time	Method
feasibility	up to 3 days	succes or not of the intervention to obtain bilairy drainage
biliary drainage duration	up to 1 month	time between intervention and drain withdrawal
quality of life	30 days	QLQ-C30 questionnary at inclusion and at D30
efficacy	15 days	decrease of bilirubine \> 50%

Trial Locations

Locations (3)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

Hopital Nord; 🇫🇷 Marseille, France

Centre Hospitalier Princesse Grace; 🇲🇨 Monaco, Monaco