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

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ClinicalTrials.gov Identifier: NCT00731419
Recruitment Status : Unknown
Verified May 2007 by University of Cape Town.
Recruitment status was:  Recruiting
First Posted : August 11, 2008
Last Update Posted : August 11, 2008
Sponsor:
Information provided by:
University of Cape Town

Tracking Information
First Submitted Date  ICMJE August 5, 2008
First Posted Date  ICMJE August 11, 2008
Last Update Posted Date August 11, 2008
Study Start Date  ICMJE June 2007
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2008)
Overall cost comparison of metal versus plastic stent in patients with limited life expectancy [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2008)
Quality of life assessment [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice
Official Title  ICMJE Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Biliary Obstruction
Intervention  ICMJE Device: SEMS
Comparing plastic and metal stents
Other Names:
  • Boston Scientific
  • biliary self-expanding metal stent
  • olympus plastic stent
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 5, 2008)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2009
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00731419
Other Study ID Numbers  ICMJE 144/2007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr J M Shaw, Department of Surgery, University of Cape Town
Study Sponsor  ICMJE University of Cape Town
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John M Shaw, FCS, MMed University of Cape Town
PRS Account University of Cape Town
Verification Date May 2007

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