Clinical trial NCT03870386: EUS Biliary Drainage vs. ERCP
Official title: EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Obstruction
Keywords: EUS
ERCP
Lumen apposing metal stent
Biliary drainage
Biliary obstruction
Pancreatic adenocarcinoma
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endoscopic ultrasound guided biliary drainage (EUS-BD) is an evolving field that has grown in popularity in the management of malignant biliary obstruction. Although Endoscopic retrograde cholangio-pancreatography (ERCP) with stent insertion has been the mainstay therapy throughout several decades, the transpapillary approach through tumor tissue is associated with significant risk for adverse events such as post-ERCP pancreatitis and stent dysfunction from tumor tissue overgrowth and ingrowth. EUS-BD, through the creation of a choledochoduodenostomy with a stent, has the potential advantage of avoiding the papilla and its associated complications while potentially improving stent patency with lower risks for tumor tissue ingrowth and/or overgrowth.


Eligibility criteria: Inclusion Criteria:

* Radiological diagnosis (with or without pathological diagnosis) of borderline resectable, locally advanced, or unresectable malignant distal biliary obstruction at least 2 cm distal to the hilum. Resectability based on tumor staging on axial imaging and surgeon evaluation.
* Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (18.9 umol/L)
* Dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or US
* Confirmation of bile duct accessibility and size of at least 1.2 cm on endoscopic ultrasound
* Karnofsky index \> 30%
* ASA score \<IV
* Provision of informed consent

Exclusion Criteria:

* Hilar obstruction (biliary obstruction \< 2 cm from the hilum)
* Uncorrectable coagulopathy and/or thrombocytopenia
* Age \< 18
* Liver metastasis involving \> 30% of the liver volume
* Liver cirrhosis with portal hypertension or ascites
* Prior biliary sphincterotomy or stent placement
* Surgically altered anatomy
* Common bile duct measuring less than 1.2 cm will be excluded
* Patient with clinical and radiological evidence of gastric outlet obstruction

Primary outcomes:
measure: Rate of re-intervention
timeFrame: 1 year
Secondary outcomes:
measure: Technical success
timeFrame: 1 year
measure: Clinical success
timeFrame: 1 year
measure: Stent patency
timeFrame: 1 year
measure: Early adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: Bristish Columbia
city: Vancouver
country: Canada
facility: St-Paul Hospital
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: St-Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier Universite de Montreal
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Hopital Charles Lemoynes
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
city: Paris
country: France
facility: Hôpital Privé des Peupliers
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Yen-I Chen, MD
role: PRINCIPAL_INVESTIGATOR
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