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

NCT ID: NCT01063634

Last Updated: 2010-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinikum Ludwigshafen

OTHER

Sponsor Role collaborator

Universitätsmedizin Mannheim

OTHER

Sponsor Role collaborator

Kliniken Ludwigsburg-Bietigheim gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Klinikum Ludiwgsburg

Locations

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Klinikum Ludwigsburg

Ludwigsburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Karel Caca, Prof. Dr.

Role: CONTACT

+49-7141-9967201

Arthur R Schmidt, Dr.

Role: CONTACT

+49-7141-9967201

Facility Contacts

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sabine weinmann

Role: primary

+49-7141-9994459

samuel raad

Role: backup

+49-7141-9994464

References

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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.

Reference Type DERIVED
PMID: 25590188 (View on PubMed)

Other Identifiers

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VIADUCT

Identifier Type: -

Identifier Source: org_study_id

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