Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction (VIADUCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Kliniken Ludwigsburg-Bietigheim gGmbH.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Klinikum Ludwigshafen
Universitätsmedizin Mannheim
Information provided by:
Kliniken Ludwigsburg-Bietigheim gGmbH
ClinicalTrials.gov Identifier:
NCT01063634
First received: February 4, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction. A Randomized, Controlled Trial

Further study details as provided by Kliniken Ludwigsburg-Bietigheim gGmbH:

Secondary Outcome Measures:
  • time to stent obstruction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with malignant obstruction of the common bile duct

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age under 18
  • Operations like Roux-Y, biliodigestive Anastomosis, BII
  • life expectancy less than 3 months
  • Karnfosky index less than 60%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063634

Contacts
Contact: Karel Caca, Prof. Dr. +49-7141-9967201 karel.caca@kliniken-lb.de
Contact: Arthur R Schmidt, Dr. +49-7141-9967201 arthur.schmidt@kliniken-lb.de

Locations
Germany
Klinikum Ludwigsburg Recruiting
Ludwigsburg, Germany, 71640
Contact: sabine weinmann    +49-7141-9994459    sabine.weinmann@kliniken-lb.de   
Contact: samuel raad    +49-7141-9994464    samuel.raad@kliniken-lb.de   
Principal Investigator: Karel Caca, Prof. Dr.         
Sponsors and Collaborators
Kliniken Ludwigsburg-Bietigheim gGmbH
Klinikum Ludwigshafen
Universitätsmedizin Mannheim
  More Information

No publications provided

Responsible Party: Medizinische Klinik I, Prof. Dr. K. Caca, Klinikum Ludiwgsburg
ClinicalTrials.gov Identifier: NCT01063634     History of Changes
Other Study ID Numbers: VIADUCT
Study First Received: February 4, 2010
Last Updated: February 4, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Kliniken Ludwigsburg-Bietigheim gGmbH:
malignant biliary obstruction
viaduct
self-expandable metal stents

ClinicalTrials.gov processed this record on July 22, 2014