Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma
|Hilar Cholangiocarcinoma||Device: biliary stent (self expandable metallic stent) Device: PS||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial|
- Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis) [ Time Frame: at 2 weeks and 4 weeks after stent insertion ]Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.
- Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis) [ Time Frame: at 2 weeks and 4 weeks after stent insertion ]Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.
- Patients Survival Times [ Time Frame: until patient died or 6 months after the last patient was enrolled ]survival times of the patients after the first stent insertion
- Cost Effective Ratio of Metallic and Plastic Stent [ Time Frame: until the patients expire (Markov model) ]cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature
|Study Start Date:||November 2007|
|Study Completion Date:||September 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
self-expandable metal stent group
Device: biliary stent (self expandable metallic stent)
metallic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
Other Name: self expandable metallic stent
Active Comparator: PS
plastic stent group
plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
Other Name: Amsterdam type plastic stent
There are two types of biliary stents: 1) the plastic stent made from polyethylene or polytetrafluoroethylene; and, 2) the metal stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10 mm. The main drawback of the plastic stent is the relatively high occlusion rate, but its advantage is the lower cost. The use of a metal stent for hilar tumor has many theoretical advantages: 1) the flexible open-mesh design should allow drainage of secondary duct branches; and, 2) its larger diameter may provide better drainage and longer patency (~3-9 months).
Whether one type of stent is superior in terms of adequacy of drainage or cost-effectiveness remains undefined. Therefore, we would conduct this study to assess the efficacy of drainage of endoscopically-inserted, unilateral, plastic stents vs. metallic stents in unresectable, complex, hilar cholangiocarcinoma patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721175
|Srinagarind Hospital. KhonKaen University.|
|Muang, KhonKaen, Thailand, 40002|
|Principal Investigator:||apichat sangchan, MD||Department of Medicine. Faculty of Medicine. KhonKaen University|