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

Jaundice Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499537
• Other study ID #: APHAGE/IPC 2010-002
• Status: Completed
• Phase: N/A
• First received: September 16, 2011
• Last updated: May 18, 2016
• Start date: January 2011
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaundice

Intervention

Device:
• biliary drainage
percutaneous transhepatic biliary drainage (PTBD)
• EUS guided biliary drainage
endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall

Locations

Country	Name	City	State
France	Hopital Nord	Marseille
France	Institut Paoli-Calmettes	Marseille
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity rate	Morbidity rate during 30 post-operative days	30 days	Yes
Secondary	efficacy	decrease of bilirubine > 50%	15 days	No
Secondary	feasibility	succes or not of the intervention to obtain bilairy drainage	up to 3 days	No
Secondary	biliary drainage duration	time between intervention and drain withdrawal	up to 1 month	No
Secondary	quality of life	QLQ-C30 questionnary at inclusion and at D30	30 days	No

External Links

•   sponsor web site