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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Apichat Sangchan, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00721175
First received: July 21, 2008
Last updated: November 21, 2011
Last verified: November 2011

July 21, 2008
November 21, 2011
November 2007
April 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Adequacy of biliary drainage of metallic stent compare to plastic stent group. [ Time Frame: 2-4 weeks after stent insertion ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00721175 on ClinicalTrials.gov Archive Site
  • Patients Survival Times [ Time Frame: until patient died or 6 months after the last patient was enrolled ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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
cost comparison [ Time Frame: until the patients expire or 6 months after stent insertion of the last patient in this study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma
Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hilar Cholangiocarcinoma
  • 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
  • Device: PS
    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
  • Experimental: SEMS
    self-expandable metal stent group
    Intervention: Device: biliary stent (self expandable metallic stent)
  • Active Comparator: PS
    plastic stent group
    Intervention: Device: PS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
September 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Unresectable complex hilar cholangiocarcinoma which diagnosis and staging based on computed tomography(CT) or magnetic resonance cholangiopancreatography (MRCP)

Exclusion Criteria:

  • Patients with ASA 4 or 5
  • Patients with liver failure.
  • Patients unable to comply with follow-up
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00721175
HE500636
No
Apichat Sangchan, Khon Kaen University
Khon Kaen University
Not Provided
Principal Investigator: apichat sangchan, MD Department of Medicine. Faculty of Medicine. KhonKaen University
Khon Kaen University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP