Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

• Sponsor: Cook Group Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00196105
• Collaborator: (none)
• Enrollment: 241
• Location: 1
• Arms: 3
• Duration (Months): 39
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive jaundice.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Neoplasms; Pancreatic Neoplasms; Jaundice, Obstructive	Device: 6 mm Nitinol Zilver Stent; Device: 10 mm Nitinol Zilver Stent; Device: 10 mm Stainless Steel Wallstent	N/A

Detailed Description

This research is being done to determine if the new, FDA-cleared Zilver metal biliary stent is better than the conventional stents. The new Zilver stent may permit more accurate placement, may avoid some potential complications and last longer than the conventional stents. The study will also examine to find the best diameter of stent by comparing standard 10 mm stents to 6 mm Zilver stents.

Study Design

• Study Type: Interventional
• Actual Enrollment: 241 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Dec 1, 2006
• Actual Study Completion Date: Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 6 mm Zilver 6 mm Nitinol Zilver Stent	Device: 6 mm Nitinol Zilver Stent
Experimental: 10 mm Zilver 10 mm Nitinol Zilver Stent	Device: 10 mm Nitinol Zilver Stent
Active Comparator: 10 mm Wallstent 10 mm Stainless Steel Wallstent	Device: 10 mm Stainless Steel Wallstent

Outcome Measures

Primary Outcome Measures

1. Patency [up to 32 months]

   Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (>= 6 months after placement).

2. Closure or Blockage of the Stent (Occlusion) [up to 32 months]

   Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.

3. Number of Days to Occlusion [up to 32 months]

4. Number of Deaths [up to 32 months]

5. Time to Death [up to 32 months]

   Overall Survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Unresectable malignancy of the extrahepatic bile duct

Exclusion Criteria:

• Age below 21 years

• Pregnancy

• Active alcohol or drug abuse

• Simultaneously participating in another investigational drug or device study.

• Allergy to stainless steel or nitinol

• Active cholangitis

• Brachytherapy

• Unable or unwilling to comply with follow up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maine Medical Center	Portland	Maine	United States	04102

Sponsors and Collaborators

• Cook Group Incorporated

Investigators

• Principal Investigator: Douglas Howell, M.D., MaineHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cook Group Incorporated
• ClinicalTrials.gov Identifier: NCT00196105
• Other Study ID Numbers: 03-MOZ
• First Posted: Sep 20, 2005
• Last Update Posted: Oct 3, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Cook Group Incorporated: Stents; Stent-graft; Minimally invasive; Biliary Tract Cancer; Pancreatic Cancer; Jaundice; Biliary Tract Neoplasms; Pancreatic Neoplasms; Jaundice, Obstructive; Zilver
• Additional relevant MeSH terms: Neoplasms; Pancreatic Neoplasms; Biliary Tract Neoplasms; Jaundice; Jaundice, Obstructive

Study Results

Participant Flow

Arm/Group Title	6 mm Zilver	10 mm Zilver	10 mm Wallstent
Arm/Group Description	6 mm Nitinol Zilver Stent	10 mm Nitinol Zilver Stent	10 mm Stainless Steel Wallstent
Period Title: Overall Study
STARTED	64	88	89
COMPLETED	60	83	82
NOT COMPLETED	4	5	7

Baseline Characteristics

Arm/Group Title	6 mm Zilver	10 mm Zilver	10 mm Wallstent	Total
Arm/Group Description	6 mm Nitinol Zilver Stent	10 mm Nitinol Zilver Stent	10 mm Stainless Steel Wallstent	Total of all reporting groups
Overall Participants	64	88	89	241
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	71.3	72.8	71.5	71.9
Sex: Female, Male (Count of Participants)
Female	27 42.2%	43 48.9%	45 50.6%	115.0 47.7%
Male	37 57.8%	45 51.1%	44 49.4%	126.0 52.3%
Biliary Sphincterotomy (Number) [Number]
Patients with Biliary Sphincterotomy	39 60.9%	50 56.8%	49 55.1%	138 57.3%
Patients without Biliary Sphincterotomy	25 39.1%	38 43.2%	40 44.9%	103 42.7%
Previous Plastic Stent (Number) [Number]
Patients with Previous Plastic Stent	32 50%	35 39.8%	47 52.8%	114 47.3%
Patients without Previous Plastic Stent	32 50%	53 60.2%	42 47.2%	127 52.7%
Tumor Diagnosis (Number) [Number]
Patients with Pancreatic Cancer	48 75%	63 71.6%	70 78.7%	181 75.1%
Patients with Metastatic Cancer	4 6.3%	12 13.6%	8 9%	24 10%
Patients with Cholangiocarcinoma	7 10.9%	5 5.7%	5 5.6%	17 7.1%
Patients with Gallbladder Cancer	1 1.6%	0 0%	2 2.2%	3 1.2%
Patients with Other Cancer	3 4.7%	7 8%	3 3.4%	13 5.4%
Patients without Tumor	1 1.6%	1 1.1%	1 1.1%	3 1.2%
Bilirubin (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	9.6 (8.7)	8.7 (7.3)	8.3 (8.7)	8.8 (8.2)
Karnofsky Index (Units on a Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a Scale]	80.5 (9.5)	80.6 (9.9)	81.2 (9.2)	80.8 (9.5)

Outcome Measures

1. Primary Outcome

Title	Patency
Description	Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (>= 6 months after placement).
Time Frame	up to 32 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	6 mm Zilver	10 mm Zilver	10 mm Wallstent
Arm/Group Description	6 mm Nitinol Zilver Stent	10 mm Nitinol Zilver Stent	10 mm Stainless Steel Wallstent
Measure Participants	64	88	89
Median (Full Range) [Days]	110	125.5	121

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	6 mm Zilver, 10 mm Zilver, 10 mm Wallstent
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.057
	Comments
	Method	Log Rank
	Comments

2. Primary Outcome

Title	Closure or Blockage of the Stent (Occlusion)
Description	Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.
Time Frame	up to 32 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	6 mm Zilver	10 mm Zilver	10 mm Wallstent
Arm/Group Description	6 mm Nitinol Zilver Stent	10 mm Nitinol Zilver Stent	10 mm Stainless Steel Wallstent
Measure Participants	64	88	89
Number [Stent Occlusions]	25	21	19

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	6 mm Zilver, 10 mm Zilver, 10 mm Wallstent
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.04
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	6 mm Zilver, 10 mm Zilver, 10 mm Wallstent
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.007
	Comments	Death is censored for Kaplan-Meier analysis.
	Method	Log Rank
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	10 mm Zilver, 10 mm Wallstent
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.69
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	6 mm Zilver, 10 mm Zilver, 10 mm Wallstent
	Comments	6 mm Zilver vs. 10 mm Zilver and 10 mm Wallstent combined
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.02
	Comments	P-value is adjusted for multiple comparisons.
	Method	Chi-squared
	Comments

3. Primary Outcome

Title	Number of Days to Occlusion
Time Frame	up to 32 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	6 mm Zilver	10 mm Zilver	10 mm Wallstent
Arm/Group Description	6 mm Nitinol Zilver Stent	10 mm Nitinol Zilver Stent	10 mm Stainless Steel Wallstent
Measure Participants	25	21	19
Median (Full Range) [Days]	115	111	103

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	6 mm Zilver, 10 mm Zilver, 10 mm Wallstent
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.16
	Comments
	Method	ANOVA
	Comments

4. Primary Outcome

Title	Number of Deaths
Time Frame	up to 32 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	6 mm Zilver	10 mm Zilver	10 mm Wallstent
Arm/Group Description	6 mm Nitinol Zilver Stent	10 mm Nitinol Zilver Stent	10 mm Stainless Steel Wallstent
Measure Participants	64	88	89
Number [Participants]	4 6.3%	6 6.8%	2 2.2%

5. Primary Outcome

Title	Time to Death
Description	Overall Survival
Time Frame	up to 32 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	6 mm Zilver	10 mm Zilver	10 mm Wallstent
Arm/Group Description	6 mm Nitinol Zilver Stent	10 mm Nitinol Zilver Stent	10 mm Stainless Steel Wallstent
Measure Participants	64	88	89
Median (Inter-Quartile Range) [Days]	132.6	186	170

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	6 mm Zilver, 10 mm Zilver, 10 mm Wallstent
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.32
	Comments
	Method	Log Rank
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	6 mm Zilver, 10 mm Zilver, 10 mm Wallstent
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.69
	Comments
	Method	Kruskal-Wallis
	Comments

Adverse Events

Adverse Event Reporting Description	No adverse events were captured due to terminal patients.
Arm/Group Title	6 mm Zilver		10 mm Zilver		10 mm Wallstent
Arm/Group Description	6 mm Nitinol Zilver Stent		10 mm Nitinol Zilver Stent		10 mm Stainless Steel Wallstent
All Cause Mortality
	6 mm Zilver		10 mm Zilver		10 mm Wallstent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	6 mm Zilver		10 mm Zilver		10 mm Wallstent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	6 mm Zilver		10 mm Zilver		10 mm Wallstent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.