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

Biliary Obstruction Clinical Trial

Official title:

Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00731419
• Other study ID #: 144/2007
• Status: Recruiting
• Phase: Phase 4
• First received: August 5, 2008
• Last updated: August 5, 2008
• Start date: June 2007
• Est. completion date: August 2009

Study information

• Verified date: May 2007
• Source: University of Cape Town
• Contact: John M Shaw, FCS, MMed
• Phone: 021-404-3042
• Email: John.Shaw[@]uct.ac.za
• Is FDA regulated: No
• Health authority: South Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Obstruction

Intervention

Device:
• SEMS
Comparing plastic and metal stents

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall cost comparison of metal versus plastic stent in patients with limited life expectancy		6 months	No
Secondary	Quality of life assessment		6 months	No