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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT01499537
First received: September 16, 2011
Last updated: May 18, 2016
Last verified: February 2016
  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

Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • Morbidity rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Morbidity rate during 30 post-operative days


Secondary Outcome Measures:
  • 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


Enrollment: 65
Study Start Date: January 2011
Study Completion Date: March 2016
Primary Completion Date: February 2016 (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)
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 16, 2011
Last Updated: May 18, 2016
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 December 02, 2016