Clinical trial NCT01499537: Prospective Randomized Study of PTC and EUS-guided Drainage of the Bile Duct
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaundice
Keywords: Stenosis of biliary ways
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Morbidity rate
timeFrame: 30 days
Secondary outcomes:
measure: efficacy
timeFrame: 15 days
measure: feasibility
timeFrame: up to 3 days
measure: biliary drainage duration
timeFrame: up to 1 month
measure: quality of life
timeFrame: 30 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Marseille
country: France
facility: Hopital Nord
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
affiliation: Institut Paoli-Calmettes
name: Erwan BORIES, MD
role: PRINCIPAL_INVESTIGATOR
References: