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Trial record 7 of 40 for:    "Klatskin tumor"

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
Sponsor:
Information provided by (Responsible Party):
Apichat Sangchan, Khon Kaen University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hilar Cholangiocarcinoma
Interventions Device: biliary stent (self expandable metallic stent)
Device: PS
Enrollment 108
Recruitment Details 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 the patients were excluded from trial after enrollment if CBD canulation is failed.
Arm/Group Title SEMS Plastic Stent
Hide Arm/Group Description self-expandable metal stent group plastic stent group
Period Title: Overall Study
Started 54 54
Completed 54 54
Not Completed 0 0
Arm/Group Title SEMS Plastic Stent Total
Hide Arm/Group Description self-expandable metal stent group plastic stent group Total of all reporting groups
Overall Number of Baseline Participants 54 54 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 108 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
49
  90.7%
49
  90.7%
98
  90.7%
>=65 years
5
   9.3%
5
   9.3%
10
   9.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 54 participants 108 participants
62.7  (10.3) 57.3  (11.7) 60.0  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 108 participants
Female
11
  20.4%
11
  20.4%
22
  20.4%
Male
43
  79.6%
43
  79.6%
86
  79.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 54 participants 54 participants 108 participants
54 54 108
1.Primary Outcome
Title Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)
Hide Description 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.
Time Frame at 2 weeks and 4 weeks after stent insertion
Hide Outcome Measure Data
Hide Analysis Population Description
All 108 participants enrolled into the study were analyzed based on ITT analysis basis.(54 participants in each group)
Arm/Group Title SEMS Plastic Stent
Hide Arm/Group Description:
SEMS (Self-expandable metal stent group)
Plastic stent group
Overall Number of Participants Analyzed 54 54
Mean (95% Confidence Interval)
Unit of Measure: proportion of participants
.7037037
(.5819144 to .825493)
.46296
(.3299707 to .5959553)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SEMS, Plastic Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Two-sample test of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -.2407407
Confidence Interval (2-Sided) 95%
-.4210726 to -.0604089
Parameter Dispersion
Type: Standard Error of the mean
Value: .0920078
Estimation Comments [Not Specified]
2.Primary Outcome
Title Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)
Hide Description 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.
Time Frame at 2 weeks and 4 weeks after stent insertion
Hide Outcome Measure Data
Hide Analysis Population Description
91 participants who had successful stent insertion were analyzed based on per protocol analysis.
Arm/Group Title SEMS Plastic Stent
Hide Arm/Group Description:
SEMS (Self-expandable metal stent group)
Plastic stent group
Overall Number of Participants Analyzed 45 46
Mean (95% Confidence Interval)
Unit of Measure: proportion of participants
0.822
(0.711 to 0.934)
0.543
(0.400 to 0.687)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SEMS, Plastic Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Two-sample test of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -.278744
Confidence Interval (2-Sided) 95%
-.4609466 to -.0965414
Parameter Dispersion
Type: Standard Error of the mean
Value: .0929622
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Patients Survival Times
Hide Description survival times of the patients after the first stent insertion
Time Frame until patient died or 6 months after the last patient was enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SEMS Plastic Stent
Hide Arm/Group Description:
SEMS (Self-expandable metal stent group)
Plastic stent group
Overall Number of Participants Analyzed 54 54
Median (Inter-Quartile Range)
Unit of Measure: days
126
(42 to 290)
49
(21 to 97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SEMS, Plastic Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Cost Effective Ratio of Metallic and Plastic Stent
Hide Description 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
Time Frame until the patients expire (Markov model)
Hide Outcome Measure Data
Hide Analysis Population Description
Simulation cohort of any number of the patients (1, 100 or 1,000 patients) enter the Markov model using transitional probabilities, cost data, utility data from this study and available literature to calculate the cost effectiveness ratio of metallic stent and plastic stent in unresectable complex hilar cholangiocarcinoma
Arm/Group Title SEMS Plastic Stent
Hide Arm/Group Description:
SEMS (Self-expandable metal stent group)
Plastic stent group
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: cost (US$) per QALY
10742 19085
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SEMS Plastic Stent
Hide Arm/Group Description self-expandable metal stent group plastic stent group
All-Cause Mortality
SEMS Plastic Stent
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SEMS Plastic Stent
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/54 (25.93%)      21/54 (38.89%)    
Hepatobiliary disorders     
cholangitis  8/54 (14.81%)  8 13/54 (24.07%)  13
pancreatitis  8/54 (14.81%)  8/54 (14.81%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
SEMS Plastic Stent
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/54 (0.00%)      1/54 (1.85%)    
Hepatobiliary disorders     
sphicterotomy bleeding  0/54 (0.00%)  1/54 (1.85%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Assist. Prof. Apichat Sangchan
Organization: Khon Kaen University
Phone: 66850004651
Responsible Party: Apichat Sangchan, Khon Kaen University
ClinicalTrials.gov Identifier: NCT00721175     History of Changes
Other Study ID Numbers: HE500636
First Submitted: July 21, 2008
First Posted: July 23, 2008
Results First Submitted: August 23, 2011
Results First Posted: December 23, 2011
Last Update Posted: December 23, 2011