Skip to main content

Table 1 Eligibility criteria

From: ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction

Inclusion criteria (must fulfill all)
 1. Radiological diagnosis (with or without pathological confirmation) 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 physician evaluation)
 2. Elevated liver tests with serum bilirubin at least three times above the upper limit of normal (1.2 mg/dl) Dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or US
 3. Karnofsky index > 30%
 4. ASA score < IV, and
 5. Provision of informed consent
Exclusion criteria (any of the following)
 1. Hilar obstruction
 2. Uncorrectable coagulopathy and/or thrombocytopenia
 3. Age < 18
 4. Liver metastasis > 30% of the liver volume
 5. Liver cirrhosis with portal hypertension or ascites
 6. Prior biliary sphincterotomy or stent placement
 7. Surgically altered anatomy
 8. Patient with clinical and radiological evidence of gastric outlet obstruction