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 plasticstent can be obtained but should be replaced by a metal stent within 4 weeks after thefirst ERCP procedure, and the patient is randomized at the time of insertion of themetal 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 ormore segments of the liver (if no segment blockage, liver metastasis is not anexclusion 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 asignificant duodenal obstruction making ERCP difficult

• previously (more than 4 weeks earlier) treated with a bile duct stent

• severe coagulation disturbance (PK-INR > 1.6)