NCT00196105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 12, 2010

Completed
Last Updated

October 3, 2011

Status Verified

September 1, 2011

Enrollment Period

3.3 years

First QC Date

September 12, 2005

Results QC Date

September 25, 2009

Last Update Submit

September 28, 2011

Conditions

Biliary Tract NeoplasmsPancreatic NeoplasmsJaundice, Obstructive

Keywords

StentsStent-graftMinimally invasiveBiliary Tract CancerPancreatic CancerJaundiceBiliary Tract NeoplasmsPancreatic NeoplasmsJaundice, ObstructiveZilver

Outcome Measures

Primary Outcomes (5)

  • 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).

    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.

    up to 32 months

  • Number of Days to Occlusion

    up to 32 months

  • Number of Deaths

    up to 32 months

  • Time to Death

    Overall Survival

    up to 32 months

Study Arms (3)

6 mm Zilver

EXPERIMENTAL

6 mm Nitinol Zilver Stent

Device: 6 mm Nitinol Zilver Stent

10 mm Zilver

EXPERIMENTAL

10 mm Nitinol Zilver Stent

Device: 10 mm Nitinol Zilver Stent

10 mm Wallstent

ACTIVE COMPARATOR

10 mm Stainless Steel Wallstent

Device: 10 mm Stainless Steel Wallstent

Interventions

6 mm Nitinol Zilver StentDEVICE
6 mm Zilver
10 mm Nitinol Zilver StentDEVICE
10 mm Zilver
10 mm Stainless Steel WallstentDEVICE
10 mm Wallstent

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unresectable malignancy of the extrahepatic bile duct

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

Related Publications (1)

  • 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.

    PMID: 19482279RESULT

MeSH Terms

Conditions

Biliary Tract NeoplasmsPancreatic NeoplasmsJaundice, ObstructiveJaundice

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Results Point of Contact

Title
Scott Snyder
Organization
Cook
ssnyder@medinst.com
765-463-7537

Study Officials

  • Douglas Howell, M.D.

    MaineHealth

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2003

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

October 3, 2011

Results First Posted

January 12, 2010

Record last verified: 2011-09

Locations

US(1)