Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.
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 earlier) treated with a bile duct stent
- severe coagulation disturbance (PK-INR > 1.6)