Trial Outcomes & Findings for Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma (NCT NCT00721175)

NCT ID: NCT00721175

Last Updated: 2011-12-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 108 participants
• Primary outcome timeframe: at 2 weeks and 4 weeks after stent insertion
• Results posted on: 2011-12-23

Participant Flow

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

the patients were excluded from trial after enrollment if CBD canulation is failed.

Participant milestones

Measure	SEMS self-expandable metal stent group	Plastic Stent plastic stent group
Overall Study STARTED	54	54
Overall Study COMPLETED	54	54
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	SEMS n=54 Participants self-expandable metal stent group	Plastic Stent n=54 Participants plastic stent group	Total n=108 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	49 Participants n=7 Participants	98 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age Continuous	62.7 years STANDARD_DEVIATION 10.3 • n=5 Participants	57.3 years STANDARD_DEVIATION 11.7 • n=7 Participants	60.0 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	43 Participants n=7 Participants	86 Participants n=5 Participants
Region of Enrollment Thailand	54 participants n=5 Participants	54 participants n=7 Participants	108 participants n=5 Participants

PRIMARY outcome

Timeframe: at 2 weeks and 4 weeks after stent insertion

Population: All 108 participants enrolled into the study were analyzed based on ITT analysis basis.(54 participants in each group)

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.

Outcome measures

Measure	SEMS n=54 Participants SEMS (Self-expandable metal stent group)	Plastic Stent n=54 Participants Plastic stent group
Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)	.7037037 proportion of participants Interval 0.5819144 to 0.825493	.46296 proportion of participants Interval 0.3299707 to 0.5959553

PRIMARY outcome

Timeframe: at 2 weeks and 4 weeks after stent insertion

Population: 91 participants who had successful stent insertion were analyzed based on per protocol analysis.

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.

Outcome measures

Measure	SEMS n=45 Participants SEMS (Self-expandable metal stent group)	Plastic Stent n=46 Participants Plastic stent group
Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)	0.822 proportion of participants Interval 0.711 to 0.934	0.543 proportion of participants Interval 0.4 to 0.687

SECONDARY outcome

Timeframe: until patient died or 6 months after the last patient was enrolled

survival times of the patients after the first stent insertion

Outcome measures

Measure	SEMS n=54 Participants SEMS (Self-expandable metal stent group)	Plastic Stent n=54 Participants Plastic stent group
Patients Survival Times	126 days Interval 42.0 to 290.0	49 days Interval 21.0 to 97.0

SECONDARY outcome

Timeframe: until the patients expire (Markov model)

Population: 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

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

Outcome measures

Measure	SEMS n=1 Participants SEMS (Self-expandable metal stent group)	Plastic Stent n=1 Participants Plastic stent group
Cost Effective Ratio of Metallic and Plastic Stent	10742 cost (US$) per QALY	19085 cost (US$) per QALY

Adverse Events

SEMS

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Plastic Stent

Serious events: 21 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	SEMS n=54 participants at risk self-expandable metal stent group	Plastic Stent n=54 participants at risk plastic stent group
Hepatobiliary disorders cholangitis	14.8% 8/54 • Number of events 8	24.1% 13/54 • Number of events 13
Hepatobiliary disorders pancreatitis	14.8% 8/54	14.8% 8/54

Other adverse events

Measure	SEMS n=54 participants at risk self-expandable metal stent group	Plastic Stent n=54 participants at risk plastic stent group
Hepatobiliary disorders sphicterotomy bleeding	0.00% 0/54	1.9% 1/54

Additional Information

Assist. Prof. Apichat Sangchan

Khon Kaen University

Phone: 66850004651

Email: apichaz@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place