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

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

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.

Study Overview

• Status: Unknown
• Conditions: Biliary Obstruction
• Intervention / Treatment: Device: SEMS

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: John M Shaw, FCS, MMed; Phone Number: 021-404-3042; Email: John.Shaw@uct.ac.za
• Study Contact Backup: Name: Jake E Krige, FCS, FACS; Phone Number: 021-404-3072; Email: Jake@curie.uct.ac.za

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • Recruiting
      • Groote Schuur Hospital
      • Contact: John M Sahw, MBBCh, FCS; Phone Number: 021-404-3042; Email: John.Shaw@uct.ac.za
      • Principal Investigator: John M Shaw, MBBCH,FCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall cost comparison of metal versus plastic stent in patients with limited life expectancy	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life assessment	6 months

Collaborators and Investigators

• Sponsor: University of Cape Town
• Investigators: Principal Investigator: John M Shaw, FCS, MMed, University of Cape Town

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Anticipated): May 1, 2009
• Study Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 5, 2008
• First Posted (Estimate): August 11, 2008

Study Record Updates

• Last Update Posted (Estimate): August 11, 2008
• Last Update Submitted That Met QC Criteria: August 5, 2008
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: stent; biliary; palliation; obstruction; malignant
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Manifestations; Hyperbilirubinemia; Jaundice
• Other Study ID Numbers: 144/2007