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Completed

NCT Number: NCT01499537

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Nord, Marseille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biliary drainage

Device

percutaneous transhepatic biliary drainage (PTBD)

EUS guided biliary drainage

Device

endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall

Primary outcomes

  1. Morbidity rate

    Time frame: 30 days

    Morbidity rate during 30 post-operative days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 26, 2011
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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