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

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

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.

Study Overview

• Status: Completed
• Conditions: Jaundice
• Intervention / Treatment: Device: biliary drainage; Device: EUS guided biliary drainage

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13009
    • Institut Paoli-Calmettes
  • Marseille, France, 13020
    • Hopital Nord
• Monaco
  • Monaco, Monaco, 98000
    • Centre Hospitalier Princesse Grace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Erwan BORIES, MD, Institut Paoli-Calmettes

Publications and helpful links

Helpful Links

• sponsor web site

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: September 16, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (ESTIMATE): December 26, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 19, 2016
• Last Update Submitted That Met QC Criteria: May 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Stenosis of biliary ways
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Manifestations; Hyperbilirubinemia; Jaundice
• Other Study ID Numbers: APHAGE/IPC 2010-002