EUS Biliary Drainage vs. ERCP

Not Applicable

Completed

• Conditions: Biliary Obstruction
• Interventions: Procedure: EUS-BD with LAMS; Procedure: ERCP

• Registration Number: NCT03870386
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-08
• Study First Submitted: 2019-03-09
• Study First Submitted QC: 2019-03-09
• Study First Posted: 2019-03-12
• Primary Completion: 2023-05-01
• Study Completion: 2023-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS-BD with LAMS	EUS-BD with LAMS	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).
Traditional transpapillary metal stent via ERCP	ERCP	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.

Primary Outcome Measures

Name	Time	Method
Rate of re-intervention	1 year	Obstruction and/or migration of stent

Secondary Outcome Measures

Name	Time	Method
Stent patency	1 year	mean time to stent obstruction or migration
Clinical success	1 year	50% decrease in bilirubin \< 2 weeks post-stent insertion or less than 25% of pre-procedure bilirubin level within 4 weeks post stent insertion
Technical success	1 year	successful insertion of a transpapillary stent or choledochoduodenostomy stent at the initial procedure at time of randomization
Early adverse events	1 year	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

Trial Locations

Locations (11)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, Bristish Columbia, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

St-Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre Hospitalier Universite de Montreal; 🇨🇦 Montréal, Quebec, Canada

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada

Hopital Charles Lemoynes; 🇨🇦 Montréal, Quebec, Canada

Jewish General Hospital; 🇨🇦 Montreal, Canada

Hôpital Privé des Peupliers; 🇫🇷 Paris, France

St-Paul Hospital; 🇨🇦 Vancouver, British Columbia, Canada