Prospective Randomized Study of PTC and EUS-guided Drainage of the Bile Duct
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Jaundice |
Device: biliary drainage Device: EUS guided biliary drainage |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Morbidity rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Morbidity rate during 30 post-operative days
- efficacy [ Time Frame: 15 days ] [ Designated as safety issue: No ]decrease of bilirubine > 50%
- feasibility [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]succes or not of the intervention to obtain bilairy drainage
- biliary drainage duration [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]time between intervention and drain withdrawal
- quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]QLQ-C30 questionnary at inclusion and at D30
| Estimated Enrollment: | 110 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Percutaneous Drainage
Percutaneous Transhepatic Biliary Drainage (PTBD)
|
Device: biliary drainage
percutaneous transhepatic biliary drainage (PTBD)
Other Name: biliary drainage
|
|
Experimental: EUS-guided drainage
endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall
|
Device: EUS guided biliary drainage
endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall
Other Name: EUS guided biliary drainage
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Dominique GENRE, MD | +33491223778 | bec@marseille.fnclcc.fr |
| Contact: Agnès BOYER CHAMMARD, MD | +33491223778 | bec@marseille.fnclcc.fr |
| France | |
| Institut Paoli-Calmettes | Recruiting |
| Marseille, France, 13009 | |
| Contact: Agnes BOYER CHAMMARD, MD +33491223778 bec@marseille.fnclcc.fr | |
| Principal Investigator: Erwan BORIES, MD | |
| Hopital Nord | Recruiting |
| Marseille, France, 13020 | |
| Contact: Marc BARTHET, MD PhD | |
| Principal Investigator: Marc BARTHET, MD PhD | |
| Monaco | |
| Centre Hospitalier Princesse Grace | Not yet recruiting |
| Monaco, Monaco, 98000 | |
| Contact: Jean-Marc DEMARQUAY, MD | |
| Principal Investigator: Jean-Marc DEMARQUAY, MD | |
| Principal Investigator: | Erwan BORIES, MD | Institut Paoli-Calmettes |
More Information
Additional Information:
No publications provided
| Responsible Party: | Institut Paoli-Calmettes |
| ClinicalTrials.gov Identifier: | NCT01499537 History of Changes |
| Other Study ID Numbers: | APHAGE/IPC 2010-002 |
| Study First Received: | September 16, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut Paoli-Calmettes:
|
Stenosis of biliary ways |
Additional relevant MeSH terms:
|
Jaundice Hyperbilirubinemia Pathologic Processes Skin Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013