Jaundice
Conditions
Keywords
Stenosis of biliary ways
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.
Interventions
DEVICEbiliary drainage
percutaneous transhepatic biliary drainage (PTBD)
endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity rate | 30 days | Morbidity rate during 30 post-operative days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| efficacy | 15 days | decrease of bilirubine \> 50% |
| 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 |
Countries
France, Monaco
Outcome results
None listed