Biliary Tract NeoplasmsNCT00196105

Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

A study testing 6 mm Nitinol Zilver Stent, 10 mm Nitinol Zilver Stent and 10 mm Stainless Steel Wallstent in people with Biliary Tract Neoplasms and Pancreatic Neoplasms, run by Cook Group Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive
What is being tested?: 6 mm Nitinol Zilver Stent, 10 mm Nitinol Zilver Stent and 10 mm Stainless Steel Wallstent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 241 participants
Where: 1 siteUnited States
Study dates: Sep 2003to Dec 2006
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Unresectable malignancy of the extrahepatic bile duct

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Maine Medical Center
Portland, Maine, 04102

Other trials in United States

About this study

Official title: Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction

Read the 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.

Conditions: Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive
Being tested: 6 mm Nitinol Zilver Stent, 10 mm Nitinol Zilver Stent, 10 mm Stainless Steel Wallstent
Keywords: Stents, Stent-graft, Minimally invasive, Biliary Tract Cancer, Pancreatic Cancer, Jaundice, Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive, Zilver
Medical subject headings: Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive, Jaundice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

6 mm Nitinol Zilver StentDevice
10 mm Nitinol Zilver StentDevice
10 mm Stainless Steel WallstentDevice

Study groups in NCT00196105
Study group	Role	What they receive
6 mm Zilver	Experimental	6 mm Nitinol Zilver Stent Receives: Device: 6 mm Nitinol Zilver Stent
10 mm Zilver	Experimental	10 mm Nitinol Zilver Stent Receives: Device: 10 mm Nitinol Zilver Stent
10 mm Wallstent	Active comparator	10 mm Stainless Steel Wallstent Receives: Device: 10 mm Stainless Steel Wallstent

What is being measured

The primary outcome is the main question the study is designed to answer.

Patency
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).
Measured: up to 32 months
Closure or Blockage of the Stent (Occlusion)
Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.
Measured: up to 32 months
Number of Days to Occlusion
Measured: up to 32 months
Number of Deaths
Measured: up to 32 months
Time to Death
Overall Survival
Measured: up to 32 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2003Dec 2006

First posted20 Sep 2005 (estimated)
Study startSep 2003
Primary completionDec 2006
Study completionDec 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Biliary Tract NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00196105
Sponsor's protocol ID: 03-MOZ
Status last verified: Sep 2011
First submitted: 12 Sep 2005
Last updated: 3 Oct 2011
Results posted: Yes, on ClinicalTrials.gov

Publications

Loew BJ, Howell DA, Sanders MK, Desilets DJ, Kortan PP, May GR, Shah RJ, Chen YK, Parsons WG, Hawes RH, Cotton PB, Slivka AA, Ahmad J, Lehman GA, Sherman S, Neuhaus H, Schumacher BM. Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial. Gastrointest Endosc. 2009 Sep;70(3):445-53. doi: 10.1016/j.gie.2008.11.018. Epub 2009 May 30.
PubMed 19482279

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma

All Biliary Tract Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction
ClinicalTrials.gov ID: NCT00196105
Acronym / sponsor ID: 03-MOZ
Conditions: Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive
Keywords: Stents, Stent-graft, Minimally invasive, Biliary Tract Cancer, Pancreatic Cancer, Jaundice, Biliary Tract Neoplasms, Pancreatic Neoplasms
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: Cook Group IncorporatedIndustry (pharma, biotech, devices)
Study start: Sep 2003
Primary completion: Dec 2006 (actual)
Study completion: Dec 2006 (actual)
First posted: 20 Sep 2005 (estimated)
Results: Posted 12 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
6 mm Zilver	Experimental	Device: 6 mm Nitinol Zilver Stent6 mm Nitinol Zilver Stent
10 mm Zilver	Experimental	Device: 10 mm Nitinol Zilver Stent10 mm Nitinol Zilver Stent
10 mm Wallstent	Active comparator	Device: 10 mm Stainless Steel Wallstent10 mm Stainless Steel Wallstent

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Unresectable malignancy of the extrahepatic bile duct

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
6 mm Nitinol Zilver Stent	Device	6 mm Zilver
10 mm Nitinol Zilver Stent	Device	10 mm Zilver
10 mm Stainless Steel Wallstent	Device	10 mm Wallstent

Primary outcome

Patency
Time frame: 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).
Closure or Blockage of the Stent (Occlusion)
Time frame: 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.
Number of Days to Occlusion
Time frame: up to 32 months
Number of Deaths
Time frame: up to 32 months
Time to Death
Time frame: up to 32 months
Overall Survival

Results and safety

Results posted to the registry on 12 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
6 mm Zilver	64	60
10 mm Zilver	88	83
10 mm Wallstent	89	82

Primary outcome: Patency

Time frame: up to 32 months. Median (Full Range). Unit: Days

Measure	6 mm Zilver n = 64	10 mm Zilver n = 88	10 mm Wallstent n = 89
Value	110 (7 to 595)	125.5 (5 to 671)	121 (0 to 961)

6 mm Zilver vs 10 mm Zilver vs 10 mm Wallstent: p = .057, Log Rank

Primary outcome: Closure or Blockage of the Stent (Occlusion)

Time frame: up to 32 months. Number. Unit: Stent Occlusions

Measure	6 mm Zilver n = 64	10 mm Zilver n = 88	10 mm Wallstent n = 89
Value	25	21	19

6 mm Zilver vs 10 mm Zilver vs 10 mm Wallstent: p = .04, Chi-squared
6 mm Zilver vs 10 mm Zilver vs 10 mm Wallstent: p = .007, Log Rank
10 mm Zilver vs 10 mm Wallstent: p = .69, Chi-squared

Primary outcome: Number of Days to Occlusion

Time frame: up to 32 months. Median (Full Range). Unit: Days

Measure	6 mm Zilver n = 25	10 mm Zilver n = 21	10 mm Wallstent n = 19
Value	115 (7 to 595)	111 (6 to 506)	103 (7 to 386)

6 mm Zilver vs 10 mm Zilver vs 10 mm Wallstent: p = .16, ANOVA

Primary outcome: Number of Deaths

Time frame: up to 32 months. Number. Unit: Participants

Measure	6 mm Zilver n = 64	10 mm Zilver n = 88	10 mm Wallstent n = 89
Value	4	6	2

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
6 mm Zilver	0 of 0	0 of 0	Not reported
10 mm Zilver	0 of 0	0 of 0	Not reported
10 mm Wallstent	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19482279Loew BJ, Howell DA, Sanders MK, Desilets DJ, Kortan PP, May GR, Shah RJ, Chen YK, Parsons WG, Hawes RH, Cotton PB, Slivka AA, Ahmad J, Lehman GA, Sherman S, Neuhaus H, Schumacher BM. Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial. Gastrointest Endosc. 2009 Sep;70(3):445-53. doi: 10.1016/j.gie.2008.11.018. Epub 2009 May 30.

Related trials for Biliary Tract Neoplasms

Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Douglas Howell, M.D. principal investigator

MaineHealth

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patency (time frame: up to 32 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00196105, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2011.