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

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ClinicalTrials.gov Identifier: NCT01499537
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Jaundice Device: biliary drainage Device: EUS guided biliary drainage

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2011
Primary Completion Date : February 2016
Study Completion Date : March 2016
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Percutaneous Drainage
Percutaneous Transhepatic Biliary Drainage (PTBD)
Device: biliary drainage
percutaneous transhepatic biliary drainage (PTBD)
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


Outcome Measures

Primary Outcome Measures :
  1. Morbidity rate [ Time Frame: 30 days ]
    Morbidity rate during 30 post-operative days


Secondary Outcome Measures :
  1. efficacy [ Time Frame: 15 days ]
    decrease of bilirubine > 50%

  2. feasibility [ Time Frame: up to 3 days ]
    succes or not of the intervention to obtain bilairy drainage

  3. biliary drainage duration [ Time Frame: up to 1 month ]
    time between intervention and drain withdrawal

  4. quality of life [ Time Frame: 30 days ]
    QLQ-C30 questionnary at inclusion and at D30


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499537


Locations
France
Institut Paoli-Calmettes
Marseille, France, 13009
Hopital Nord
Marseille, France, 13020
Monaco
Centre Hospitalier Princesse Grace
Monaco, Monaco, 98000
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Erwan BORIES, MD Institut Paoli-Calmettes
More Information

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01499537     History of Changes
Other Study ID Numbers: APHAGE/IPC 2010-002
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: February 2016

Keywords provided by Institut Paoli-Calmettes:
Stenosis of biliary ways

Additional relevant MeSH terms:
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms