EUS Biliary Drainage vs. ERCP

McGill University Health Centre/Research Institute of the McGill University Health Centre144 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

144

Conditions

Biliary Obstruction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, Bristish Columbia, Canada

St-Paul Hospital

Vancouver, British Columbia, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

St-Michael's Hospital

Toronto, Ontario, Canada

Centre Hospitalier Universite de Montreal

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Hopital Charles Lemoynes

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Canada

...and 1 more locations

Outcomes

Primary Outcomes

Rate of re-intervention

Obstruction and/or migration of stent

Time frame: 1 year

Secondary Outcomes

Technical success

successful insertion of a transpapillary stent or choledochoduodenostomy stent at the initial procedure at time of randomization

Time frame: 1 year

Clinical success

50% decrease in bilirubin \< 2 weeks post-stent insertion or less than 25% of pre-procedure bilirubin level within 4 weeks post stent insertion

Time frame: 1 year

Stent patency

mean time to stent obstruction or migration

Time frame: 1 year

Early adverse events

as per the ASGE lexicon for endoscopic adverse events13 including post-procedural pancreatitis defined as new or worsening abdominal pain persistent for at least 24 hours and requiring analgesics after ERCP or EUS-BD with an elevated amylase or lipase of greater than three times the upper limit of normal, peri-procedural bleeding defined as hematemesis and/or melena or hemoglobin drop \> 2 g, intestinal perforation defined as evidence of air or luminal contents outside the GI tract, and cholangitis \>38 Celsius for greater than 24 hours with cholestatic liver enzymes

Time frame: 1 year