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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hilar Cholangiocarcinoma
 Device: biliary stent (self expandable metallic stent)
Device: PS
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 108
Study Start Date: November 2007
Study Completion Date: September 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SEMS
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
 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721175

Locations
Thailand
Srinagarind Hospital. KhonKaen University.
Muang, KhonKaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: apichat sangchan, MD Department of Medicine. Faculty of Medicine. KhonKaen University
  More Information

Additional Information:
Research affairs. Faculty of Medicine. KhonKaen University  This link exits the ClinicalTrials.gov site
KhonKaen University Ethics Committee for Human Research  This link exits the ClinicalTrials.gov site
This study is the part of research project of Liver and Cholangiocarcinoma Research Center in year 2007  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Apichat Sangchan, Assist. Prof., Khon Kaen University
ClinicalTrials.gov Identifier: NCT00721175     History of Changes
Other Study ID Numbers: HE500636
Study First Received: July 21, 2008
Results First Received: August 23, 2011
Last Updated: November 21, 2011
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
biliary stent
plastic stent
metallic stent
Complex hilar cholangiocarcinoma (Bismuth type II,III,IV)

Additional relevant MeSH terms:
Cholangiocarcinoma
Klatskin's Tumor
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013