Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Biliary Obstruction
Both
Biliary Obstruction
Trial Information
Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice
Inclusion Criteria:
- Symptomatic jaundice secondary to malignant distal CBD stricture
- Contra-indication to resection (advanced disease/advanced age/poor surgical risk)
Exclusion Criteria:
- Hilar/proximal CBD obstruction
- ECOG performance status 3 or 4
- Duodenal obstruction
- Previous stent placement
- Inability to comply with follow-up
- Ascites and liver metastases
- Not possible to stent endoscopically
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Overall cost comparison of metal versus plastic stent in patients with limited life expectancy
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
John M Shaw, FCS, MMed
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Cape Town
Authority:
South Africa: National Health Research Ethics Council
Study ID:
144/2007
NCT ID:
NCT00731419
Start Date:
June 2007
Completion Date:
August 2009
Related Keywords:
- Biliary Obstruction
- biliary
- obstruction
- malignant
- stent
- palliation
- Jaundice
Name | Location |
|---|
