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

University of Cape Town (UCT)

Status and phase: Unknown; Phase 4

Conditions: Biliary Obstruction

Treatments: Device: SEMS

Study type: Interventional

Funder types: Other

Identifiers

NCT00731419

144/2007

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

SEMS

Active Comparator group

Description:

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

Treatment:

Device: SEMS

Plastic stent

Active Comparator group

Treatment:

Device: SEMS