A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.

Inclusion Criteria:

• 18years of age or older
• informed consent obtained after oral and written information
• clinical data in accordance with a malignant bile duct obstruction
• imaging evidence: (ultrasonography (US), computed tomography (CT) or magnetic resonance imaging (MRI) shows signs of extrahepatic malignant common bile duct obstruction
• typical ERCP findings of a malignant common bile duct stenosis
• proximal margin of the bile duct stenosis ≥2 cm from the hepatic confluence
• bilirubin > 50 micromol/L
• radical surgery not deemed possible

Exclusion Criteria:

• patients with active hepatitis or other jaundice-causing hepatic diseases
• informed consent not obtained or patient unable to give informed consent
• patients with no understanding of English, Afrikaans or Xhosa where it is not possible to obtain informed consent
• metastasis with multiple significant intrahepatic stenosis causing blockage of one or more segments of the liver (liver metastasis otherwise not an exclusion criteria)
• the patient is a possible 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 < 2 cm from the hepatic confluence
• previous BII or Roux-en-Y gastric reconstruction
• significant duodenal obstruction making ERCP difficult
• previous bile duct stent