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

• Sponsor: Khon Kaen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00721175
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hilar Cholangiocarcinoma	Device: biliary stent (self expandable metallic stent); Device: PS	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Amsterdam type plastic stent

Outcome Measures

Primary Outcome Measures

1. Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis) [at 2 weeks and 4 weeks after stent insertion]

   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.

2. Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis) [at 2 weeks and 4 weeks after stent insertion]

   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

1. Patients Survival Times [until patient died or 6 months after the last patient was enrolled]

   survival times of the patients after the first stent insertion

2. Cost Effective Ratio of Metallic and Plastic Stent [until the patients expire (Markov model)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• KhonKaen University Ethics Committee for Human Research

Publications

• De Palma GD, Pezzullo A, Rega M, Persico M, Patrone F, Mastantuono L, Persico G. Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study. Gastrointest Endosc. 2003 Jul;58(1):50-3.
• Freeman ML, Overby C. Selective MRCP and CT-targeted drainage of malignant hilar biliary obstruction with self-expanding metallic stents. Gastrointest Endosc. 2003 Jul;58(1):41-9.
• Wagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy. 1993 Mar;25(3):213-8.

• Responsible Party: Apichat Sangchan, Assist. Prof., Khon Kaen University
• ClinicalTrials.gov Identifier: NCT00721175
• Other Study ID Numbers: HE500636
• First Posted: Jul 23, 2008
• Last Update Posted: Dec 23, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Apichat Sangchan, Assist. Prof., Khon Kaen University: biliary stent; plastic stent; metallic stent; Complex hilar cholangiocarcinoma (Bismuth type II,III,IV)
• Additional relevant MeSH terms: Cholangiocarcinoma; Klatskin Tumor

Study Results

Participant Flow

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

Arm/Group Title	SEMS	Plastic Stent
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

Baseline Characteristics

Arm/Group Title	SEMS	Plastic Stent	Total
Arm/Group Description	self-expandable metal stent group	plastic stent group	Total of all reporting groups
Overall Participants	54	54	108
Age (Count of Participants)
<=18 years	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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.7 (10.3)	57.3 (11.7)	60.0 (11.3)
Sex: Female, Male (Count of Participants)
Female	11 20.4%	11 20.4%	22 20.4%
Male	43 79.6%	43 79.6%	86 79.6%
Region of Enrollment (participants) [Number]
Thailand	54 100%	54 100%	108 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)
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

Outcome Measure Data

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
Arm/Group Description	SEMS (Self-expandable metal stent group)	Plastic stent group
Measure Participants	54	54
Mean (95% Confidence Interval) [proportion of participants]	.7037037 1.3%	.46296 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SEMS, Plastic Stent
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	Two-sample test of proportion
	Comments
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

2. Secondary Outcome

Title	Patients Survival Times
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SEMS	Plastic Stent
Arm/Group Description	SEMS (Self-expandable metal stent group)	Plastic stent group
Measure Participants	54	54
Median (Inter-Quartile Range) [days]	126	49

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SEMS, Plastic Stent
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0021
	Comments
	Method	Log Rank
	Comments

3. Secondary Outcome

Title	Cost Effective Ratio of Metallic and Plastic Stent
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)

Outcome Measure Data

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
Arm/Group Description	SEMS (Self-expandable metal stent group)	Plastic stent group
Measure Participants	1	1
Number [cost (US$) per QALY]	10742	19085

4. Primary Outcome

Title	Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)
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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SEMS	Plastic Stent
Arm/Group Description	SEMS (Self-expandable metal stent group)	Plastic stent group
Measure Participants	45	46
Mean (95% Confidence Interval) [proportion of participants]	0.822 1.5%	0.543 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SEMS, Plastic Stent
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Two-sample test of proportion
	Comments
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

Adverse Events

Arm/Group Title	SEMS		Plastic Stent
Arm/Group Description	self-expandable metal stent group		plastic stent group
All Cause Mortality
	SEMS		Plastic Stent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SEMS		Plastic Stent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/54 (25.9%)		21/54 (38.9%)
Hepatobiliary disorders
cholangitis	8/54 (14.8%)	8	13/54 (24.1%)	13
pancreatitis	8/54 (14.8%)		8/54 (14.8%)
Other (Not Including Serious) Adverse Events
	SEMS		Plastic Stent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		1/54 (1.9%)
Hepatobiliary disorders
sphicterotomy bleeding	0/54 (0%)		1/54 (1.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.