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

• Sponsor: Institut Paoli-Calmettes (Other)
• Overall Status: Completed
• CT.gov ID: NCT01499537
• Collaborator: (none)
• Enrollment: 65
• Locations: 3
• Arms: 2
• Duration (Months): 62
• Patients Per Site: 21.7
• Patients Per Site Per Month: 0.3

Study Details

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	Phase
Jaundice	Device: biliary drainage; Device: EUS guided biliary drainage	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2011
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Mar 1, 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 [30 days]

   Morbidity rate during 30 post-operative days

Secondary Outcome Measures

1. efficacy [15 days]

   decrease of bilirubine > 50%

2. feasibility [up to 3 days]

   succes or not of the intervention to obtain bilairy drainage

3. biliary drainage duration [up to 1 month]

   time between intervention and drain withdrawal

4. quality of life [30 days]

   QLQ-C30 questionnary at inclusion and at D30

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Institut Paoli-Calmettes	Marseille		France	13009
2	Hopital Nord	Marseille		France	13020
3	Centre Hospitalier Princesse Grace	Monaco		Monaco	98000

Sponsors and Collaborators

• Institut Paoli-Calmettes

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• sponsor web site

Publications

None provided.

• Responsible Party: Institut Paoli-Calmettes
• ClinicalTrials.gov Identifier: NCT01499537
• Other Study ID Numbers: APHAGE/IPC 2010-002
• First Posted: Dec 26, 2011
• Last Update Posted: May 19, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by Institut Paoli-Calmettes: Stenosis of biliary ways
• Additional relevant MeSH terms: Jaundice

Study Results

No Results Posted as of May 19, 2016