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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Jaundice

Intervention / Treatment
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* Device: biliary drainage
* Device: EUS guided biliary drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous Drainage<br>Percutaneous Transhepatic Biliary Drainage (PTBD) | Device: biliary drainage<br>* percutaneous transhepatic biliary drainage (PTBD)<br>|
| Experimental: EUS-guided drainage<br>endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall | Device: EUS guided biliary drainage<br>* endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity rate | Morbidity rate during 30 post-operative days | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stenosis of biliary ways