EUS Biliary Drainage vs. ERCP

McGill University

Status: Completed

Conditions: Biliary Obstruction

Treatments: Procedure: ERCP; Procedure: EUS-BD with LAMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03870386

F11-36171

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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144 participants in 2 patient groups

EUS-BD with LAMS

Experimental group

Description:

A curvilinear endoscope is inserted orally and advanced to the duodenal bulb. Biliary accessibility is confirmed via EUS and with Doppler to rule out any intervening vessels. For common bile ducts \< 15 mm in diameter, the biliary access is established via needle puncture with a 19-gauge needle followed by advancement of a 0.035 or 0.025 inch guidewire. A LAMS (AxiosTM) will then be inserted with cautery assistance without tract dilation and deployed. For common bile ducts \> 15 mm, the need for initial needle puncture and wire insertion is at the discretion of the endoscopist. A cholangiogram is then performed through the LAMS with contrast injection. The choice of stent size will be at the discretion of the endoscopist (8 x 8 mm or 6 x 8 mm).

Treatment:

Procedure: EUS-BD with LAMS

Traditional transpapillary metal stent via ERCP

Active Comparator group

Description:

A duodenoscope is advanced orally to the papilla. The bile duct is then cannulated with a sphincterotome using the guidewire-assisted technique. A cholangiogram is then performed followed by insertion of a self-expanding metal biliary stent. The performance of a biliary sphincterotomy prior to stent insertion and the choice of stent size (10x 40 mm, 10 x 60 mm, 10x 80 mm) will be at the discretion of the endoscopist.

Treatment:

Procedure: ERCP