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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Jaundice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Percutaneous Drainage

Percutaneous Transhepatic Biliary Drainage (PTBD)

Group Type ACTIVE_COMPARATOR

biliary drainage

Intervention Type DEVICE

percutaneous transhepatic biliary drainage (PTBD)

EUS-guided drainage

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

Group Type EXPERIMENTAL

EUS guided biliary drainage

Intervention Type DEVICE

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

Interventions

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biliary drainage

percutaneous transhepatic biliary drainage (PTBD)

Intervention Type DEVICE

EUS guided biliary drainage

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No