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
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice

Resource links provided by NLM:


Further study details as provided by University of Cape Town:

Primary Outcome Measures:
  • Overall cost comparison of metal versus plastic stent in patients with limited life expectancy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
Active Comparator: SEMS
Self expanding metal stent compared to plastic stent. Both recognised forms of treatment for condition
Device: SEMS
Comparing plastic and metal stents
Other Names:
  • Boston Scientific
  • biliary self-expanding metal stent
  • olympus plastic stent
Active Comparator: Plastic stent Device: SEMS
Comparing plastic and metal stents
Other Names:
  • Boston Scientific
  • biliary self-expanding metal stent
  • olympus plastic stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731419

Contacts
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

Locations
South Africa
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         
Sponsors and Collaborators
University of Cape Town
Investigators
Principal Investigator: John M Shaw, FCS, MMed University of Cape Town
  More Information

No publications provided

Responsible Party: Dr J M Shaw, Department of Surgery, University of Cape Town
ClinicalTrials.gov Identifier: NCT00731419     History of Changes
Other Study ID Numbers: 144/2007
Study First Received: August 5, 2008
Last Updated: August 5, 2008
Health Authority: South Africa: National Health Research Ethics Council

Keywords provided by University of Cape Town:
biliary
obstruction
malignant
stent
palliation

Additional relevant MeSH terms:
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014