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

NCT00731419 | Unknown Phase 4

• 1 other identifier: 144/2007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Obstruction

Keywords

biliary; obstruction; malignant; stent; palliation

Outcome Measures

Primary Outcomes (1)

• Overall cost comparison of metal versus plastic stent in patients with limited life expectancy

  6 months

Secondary Outcomes (1)

• Quality of life assessment

  6 months

Study Arms (2)

SEMS

ACTIVE COMPARATOR

Self expanding metal stent compared to plastic stent. Both recognised forms of treatment for condition

Device: SEMS

Plastic stent

ACTIVE COMPARATOR

Device: SEMS

Interventions

SEMS DEVICE

Comparing plastic and metal stents

Also known as: Boston Scientific, biliary self-expanding metal stent, olympus plastic stent

Plastic stent; SEMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic jaundice secondary to malignant distal CBD stricture
• Contra-indication to resection (advanced disease/advanced age/poor surgical risk)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Cape, 7925, South Africa

RECRUITING

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• John M Shaw, FCS, MMed

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John M Shaw, FCS, MMed

CONTACT

021-404-3042; John.Shaw@uct.ac.za

Jake E Krige, FCS, FACS

CONTACT

021-404-3072; Jake@curie.uct.ac.za

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 11, 2008
• Study Start: June 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 11, 2008

Record last verified: 2007-05

Locations

ZA (1)