UnknownNot Applicable

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

Germany76 participantsStarted 2010-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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%

Trial details

NCT IDNCT01063634

SponsorKliniken Ludwigsburg-Bietigheim gGmbH

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-01

Contact for this trial

Karel Caca, Prof. Dr.

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

View on ClinicalTrials.gov More To Evaluate Patency of the Viaduct Stent in Comparison to Metal Stents trials