Biliary Obstruction
Conditions
Keywords
EUS, ERCP, Lumen apposing metal stent, Biliary drainage, Biliary obstruction, Pancreatic adenocarcinoma
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.
Interventions
PROCEDUREEUS-BD with LAMS
Endoscopic ultrasound guided insertion of lumen apposing metal stent forming a choledochoduodenostomy
PROCEDUREERCP
Endoscopic retrograde cholangiopancreatography to localize and cannulate the bile duct using the guidewire-assisted technique.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-intervention | 1 year | Obstruction and/or migration of stent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada, France
Outcome results
None listed