Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Cape Town |
---|---|
Information provided by: | University of Cape Town |
ClinicalTrials.gov Identifier: | NCT00731419 |
Background:
When considering any malignancy with limited life expectancy, palliation and quality of life are paramount. Owing to the limited centres offering ERCP and endoscopic palliation in the South African state sector, patients often travel vast distances and spend large amounts of time away from family and social support structures, severely impairing their quality of life. Stent occlusion with resultant readmission to an ERCP accredited centre obviously compounds this problem.
The hypothesis we propose to test is whether metal stents as a primary procedure result in better patency rates, are more cost effective and improve quality of life than plastic stents. We propose to do this by means of a randomised trial determining the best method of palliation for inoperable distal common bile duct malignancies in the South African context.
Primary end-point Assessing the cost of metal versus plastic stenting in inoperable malignant distal common bile duct strictures in patients with expected survival of 3 months or more as palliation of symptomatic obstructive jaundice. Cost to be assessed in terms of hardware, hospital stay and readmissions for stent occlusion(patency) and complications Secondary end-point Assessing quality of life using a validated scoring system(EORTC QLQ 30) in patients receiving a metal or plastic biliary stent as definitive means of palliation of malignant obstructive jaundice
Hypothesis to be tested Metal stents are superior to plastic stents in terms of patency, resulting in more cost effective palliation of inoperable malignant jaundice and better quality of life due to fewer stent occlusions/episodes of cholangitis.
Condition | Intervention | Phase |
---|---|---|
Biliary Obstruction |
Device: SEMS |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice |
Estimated Enrollment: | 100 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
SEMS: Active Comparator
Self expanding metal stent compared to plastic stent. Both recognised forms of treatment for condition
|
Device: SEMS
Comparing plastic and metal stents
|
Plastic stent: Active Comparator |
Device: SEMS
Comparing plastic and metal stents
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: John M Shaw, FCS, MMed | 021-404-3042 | John.Shaw@uct.ac.za |
Contact: Jake E Krige, FCS, FACS | 021-404-3072 | Jake@curie.uct.ac.za |
South Africa, Western Cape | |
Groote Schuur Hospital | Recruiting |
Cape Town, Western Cape, South Africa, 7925 | |
Contact: John M Sahw, MBBCh, FCS 021-404-3042 John.Shaw@uct.ac.za | |
Principal Investigator: John M Shaw, MBBCH,FCS |
Principal Investigator: | John M Shaw, FCS, MMed | University of Cape Town |
Responsible Party: | Department of Surgery, University of Cape Town ( Dr J M Shaw ) |
Study ID Numbers: | 144/2007 |
Study First Received: | August 5, 2008 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00731419 |
Health Authority: | South Africa: National Health Research Ethics Council |
biliary obstruction malignant stent palliation |
Jaundice |