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

K

Kliniken Ludwigsburg-Bietigheim gGmbH

Status

Unknown

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT01063634
VIADUCT

Details and patient eligibility

About

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.

Enrollment

76 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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%

Trial contacts and locations

1

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Central trial contact

Karel Caca, Prof. Dr.; Arthur R Schmidt, Dr.

Data sourced from clinicaltrials.gov

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