Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by University of Cape Town.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Cape Town
ClinicalTrials.gov Identifier:
NCT00731419
First received: August 5, 2008
Last updated: NA
Last verified: May 2007
History: No changes posted

August 5, 2008
August 5, 2008
June 2007
May 2009   (final data collection date for primary outcome measure)
Overall cost comparison of metal versus plastic stent in patients with limited life expectancy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Quality of life assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice
Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Biliary Obstruction
Device: SEMS
Comparing plastic and metal stents
Other Names:
  • Boston Scientific
  • biliary self-expanding metal stent
  • olympus plastic stent
  • Active Comparator: SEMS
    Self expanding metal stent compared to plastic stent. Both recognised forms of treatment for condition
    Intervention: Device: SEMS
  • Active Comparator: Plastic stent
    Intervention: Device: SEMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
August 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
 
NCT00731419
144/2007
No
Dr J M Shaw, Department of Surgery, University of Cape Town
University of Cape Town
Not Provided
Principal Investigator: John M Shaw, FCS, MMed University of Cape Town
University of Cape Town
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP