Clinical trial NCT00731419: Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice
Official title: Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Biliary Obstruction
Keywords: biliary
obstruction
malignant
stent
palliation
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2008-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall cost comparison of metal versus plastic stent in patients with limited life expectancy
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: John M Shaw, FCS, MMed
role: PRINCIPAL_INVESTIGATOR
References: