EUS Biliary Drainage vs. ERCP

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Biliary Obstruction

Intervention / Treatment
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* Procedure: EUS-BD with LAMS
* Procedure: ERCP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS-BD with LAMS<br>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). | Procedure: EUS-BD with LAMS<br>* Endoscopic ultrasound guided insertion of lumen apposing metal stent forming a choledochoduodenostomy<br>|
| Active Comparator: Traditional transpapillary metal stent via ERCP<br>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. | Procedure: ERCP<br>* Endoscopic retrograde cholangiopancreatography to localize and cannulate the bile duct using the guidewire-assisted technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of re-intervention | Obstruction and/or migration of stent | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | successful insertion of a transpapillary stent or choledochoduodenostomy stent at the initial procedure at time of randomization | 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 | 1 year | 
| Stent patency | mean time to stent obstruction or migration | 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS, ERCP, Lumen apposing metal stent, Biliary drainage, Biliary obstruction, Pancreatic adenocarcinoma