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

Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction. A Randomized, Controlled Trial

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01063634

Acronym

VIADUCT

Enrollment

Registered

2010-02-05

Start date

2010-01-31

Completion date

2012-01-31

Last updated

2010-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

malignant biliary obstruction, viaduct, self-expandable metal stents

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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%

Design outcomes

Secondary

Measure	Time frame
time to stent obstruction	1 year

Countries

Germany

Contacts

Primary ContactKarel Caca, Prof. Dr.

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

Backup ContactArthur R Schmidt, Dr.

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

Outcome results