Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction
Not Applicable
- Conditions
- Biliary StrictureCancer of the PancreasBile Duct Obstruction, ExtrahepaticCancer of the Bile Duct
- Registration Number
- NCT03821025
- Lead Sponsor
- University of Cape Town
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of patients without stent failure 12 months Number of patients without Stent failure (jaundice) or death with a patent stent
- Secondary Outcome Measures
Name Time Method Stent deployment failure During procedure Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation
Cost 12 months The differance in treatment costs between the two groups, measured in USD
Overall survival 12 months Number of patietns alive in each group at 12 months
Trial Locations
- Locations (1)
Groote Schuur Hospital
🇿🇦Cape Town, Western Cape, South Africa
Groote Schuur Hospital🇿🇦Cape Town, Western Cape, South AfricaMarc M Bernon, MBBChContact+27 (0)21 404 3042mm.bernon@uct.ac.za