Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction

Inclusion Criteria: * 20 years of age or older * oral and written information given and informed consent obtained * clinical data in accordance with malignant bile duct obstruction * ultrasonography signs of extrahepatic malignant common bile duct obstruction * typical radiological findings at ERCP of malignant common bile duct stenosis * proximal margin of the bile duct stenosis at least 2 cm from the hepatic confluence * bilirubin \> 50 micromol/L * radical surgery estimated not possible (temporary stenting with insertion of a plastic stent can be obtained but should be replaced by a metal stent within 4 weeks after the first ERCP procedure, and the patient is randomized at the time of insertion of the metal stent) Exclusion Criteria: * patients with active hepatitis or other hepatic diseases that may cause jaundice * informed consent not obtained * metastasis with numerous significant intrahepatic stenosis causing blockage of one or more segments of the liver (if no segment blockage, liver metastasis is not an exclusion criteria) * the patient is probably a candidate for surgical resection * suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations) * the proximal end of the stenosis is located within 2 cm from the hepatic confluence * the patient has previously undergone BII or Roux-en-Y gastric resection, or has a significant duodenal obstruction making ERCP difficult * previously (more than 4 weeks earl…