NCT01063634

Brief Summary

This is a non-inferiority randomized study to compare a plastic stent without central lumen (VIADUCT) with self-expandable metal stents for treatment of malignant obstruction of the common bile duct. It is a non-interventional study, a CE mark for the VIADUCT stent exists.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 5, 2010

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

February 4, 2010

Last Update Submit

February 4, 2010

Conditions

To Evaluate Patency of the Viaduct Stent in Comparison to Metal Stents

Keywords

malignant biliary obstructionviaductself-expandable metal stents

Outcome Measures

Secondary Outcomes (1)

  • time to stent obstruction

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with malignant obstruction of the common bile duct

You may qualify if:

  • histologically proven malignant biliary stenosis
  • signs of biliary obstruction
  • informed consent

You may not qualify if:

  • age under 18
  • Operations like Roux-Y, biliodigestive Anastomosis, BII
  • life expectancy less than 3 months
  • Karnfosky index less than 60%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

RECRUITING

Related Publications (1)

  • Schmidt A, Riecken B, Rische S, Klinger C, Jakobs R, Bechtler M, Kahler G, Dormann A, Caca K. Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study. Endoscopy. 2015 May;47(5):430-6. doi: 10.1055/s-0034-1391232. Epub 2015 Jan 15.

    PMID: 25590188DERIVED

Central Study Contacts

Karel Caca, Prof. Dr.

CONTACT

+49-7141-9967201karel.caca@kliniken-lb.de

Arthur R Schmidt, Dr.

CONTACT

+49-7141-9967201arthur.schmidt@kliniken-lb.de

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 5, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

February 5, 2010

Record last verified: 2010-02

Locations

DE(1)