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

NCT01499537 | Completed

• 1 other identifier: APHAGE/IPC 2010-002
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 3

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.

Conditions

Jaundice

Keywords

Stenosis of biliary ways

Outcome Measures

Primary Outcomes (1)

• Morbidity rate

  Morbidity rate during 30 post-operative days

  30 days

Secondary Outcomes (4)

• efficacy

  15 days

• feasibility

  up to 3 days

• biliary drainage duration

  up to 1 month

• quality of life

  30 days

Study Arms (2)

Percutaneous Drainage

ACTIVE COMPARATOR

Percutaneous Transhepatic Biliary Drainage (PTBD)

Device: biliary drainage

EUS-guided drainage

EXPERIMENTAL

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

Device: EUS guided biliary drainage

Interventions

biliary drainage DEVICE

percutaneous transhepatic biliary drainage (PTBD)

Percutaneous Drainage

EUS guided biliary drainage DEVICE

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

EUS-guided drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>= 18
• Karnofsky \>= 50%
• biliary stenosis (malignant or benign stricture)with failure of endoscopic retrograde cholangiopancreatography
• signed informed consent

You may not qualify if:

• isolated biliary stenosis of right hepatic canal
• percutaneous biliary drainage \< 10 days
• laparotomy \< 10 days
• contra-indication to the procedure
• pregnant women

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (3)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Hopital Nord

Marseille, 13020, France

Location

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

Related Links

• sponsor web site

MeSH Terms

Conditions

Jaundice

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Erwan BORIES, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: December 26, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 19, 2016

Record last verified: 2016-02

Locations

FR (2); MO (1)