Clinical Trial: Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial

Brief Summary: The purpose of this study is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.

Detailed Summary:

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.


Sponsor: Khon Kaen University

Current Primary Outcome:

  • 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.


Original Primary Outcome: Adequacy of biliary drainage of metallic stent compare to plastic stent group. [ Time Frame: 2-4 weeks after stent insertion ]

Current Secondary Outcome:

  • 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


Original Secondary Outcome: cost comparison [ Time Frame: until the patients expire or 6 months after stent insertion of the last patient in this study ]

Information By: Khon Kaen University

Dates:
Date Received: July 21, 2008
Date Started: November 2007
Date Completion:
Last Updated: November 21, 2011
Last Verified: November 2011