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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
percutaneous transhepatic biliary drainage (PTBD)
endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall
Institut Paoli-Calmettes
Marseille, France
Hopital Nord
Marseille, France
Centre Hospitalier Princesse Grace
Monaco, Monaco
Morbidity rate
Morbidity rate during 30 post-operative days
Time frame: 30 days
efficacy
decrease of bilirubine \> 50%
Time frame: 15 days
feasibility
succes or not of the intervention to obtain bilairy drainage
Time frame: up to 3 days
biliary drainage duration
time between intervention and drain withdrawal
Time frame: up to 1 month
quality of life
QLQ-C30 questionnary at inclusion and at D30
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.