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
Results First Received: August 23, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hilar Cholangiocarcinoma
Interventions: Device: biliary stent (self expandable metallic stent)
Device: PS

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between November 2007 and March 2010, one hundred and eight patients who visited medical clinic at Srinagarind hospital, Khon Kaen University were randomized into the study

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
the patients were excluded from trial after enrollment if CBD canulation is failed.

Reporting Groups
  Description
SEMS self-expandable metal stent group
Plastic Stent plastic stent group

Participant Flow:   Overall Study
    SEMS     Plastic Stent  
STARTED     54     54  
COMPLETED     54     54  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SEMS self-expandable metal stent group
Plastic Stent plastic stent group
Total Total of all reporting groups

Baseline Measures
    SEMS     Plastic Stent     Total  
Number of Participants  
[units: participants]
  54     54     108  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     49     49     98  
>=65 years     5     5     10  
Age  
[units: years]
Mean ± Standard Deviation
  62.7  ± 10.3     57.3  ± 11.7     60.0  ± 11.3  
Gender  
[units: participants]
     
Female     11     11     22  
Male     43     43     86  
Region of Enrollment  
[units: participants]
     
Thailand     54     54     108  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   Patients Survival Times   [ Time Frame: until patient died or 6 months after the last patient was enrolled ]

4.  Secondary:   Cost Effective Ratio of Metallic and Plastic Stent   [ Time Frame: until the patients expire (Markov model) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Assist. Prof. Apichat Sangchan
Organization: Khon Kaen University
phone: 66850004651
e-mail: apichaz@yahoo.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Apichat Sangchan, 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