Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma
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|ClinicalTrials.gov Identifier: NCT00721175|
Recruitment Status : Completed
First Posted : July 23, 2008
Results First Posted : December 23, 2011
Last Update Posted : December 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hilar Cholangiocarcinoma||Device: biliary stent (self expandable metallic stent) Device: PS||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial|
|Study Start Date :||November 2007|
|Primary Completion Date :||April 2010|
|Study Completion Date :||September 2010|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721175
|Srinagarind Hospital. KhonKaen University.|
|Muang, KhonKaen, Thailand, 40002|
|Principal Investigator:||apichat sangchan, MD||Department of Medicine. Faculty of Medicine. KhonKaen University|