To Evaluate Patency of the Viaduct Stent in Comparison to Metal StentsVIADUCTNCT01063634
Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction
An observational study of To Evaluate Patency of the Viaduct Stent in Comparison to Metal Stents, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Evaluate Patency of the Viaduct Stent in Comparison to Metal Stents
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with malignant obstruction of the common bile duct
Who may be able to join
- histologically proven malignant biliary stenosis
- signs of biliary obstruction
- informed consent
Who cannot join
- age under 18
- Operations like Roux-Y, biliodigestive Anastomosis, BII
- life expectancy less than 3 months
- Karnfosky index less than 60%
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Ludwigsburg
Ludwigsburg, 71640
sabine weinmann, +49-7141-9994459, sabine.weinmann@kliniken-lb.de
samuel raad, +49-7141-9994464, samuel.raad@kliniken-lb.de
About this study
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
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.
- Keywords
- malignant biliary obstruction, viaduct, self-expandable metal stents
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Evaluate Patency of the Viaduct Stent in Comparison to Metal StentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Ludwigshafen, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063634
- Sponsor's protocol ID
- VIADUCT
- Acronym
- VIADUCT
- Status last verified
- Feb 2010
- First submitted
- 4 Feb 2010
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25590188
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01063634
- Acronym / sponsor ID
- VIADUCT / VIADUCT
- Keywords
- malignant biliary obstruction, viaduct, self-expandable metal stents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbHUniversity, hospital or other
- Collaborators
- Klinikum Ludwigshafen, Universitätsmedizin Mannheim
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with malignant obstruction of the common bile duct
Key inclusion criteria (3 listed)
- histologically proven malignant biliary stenosis
- signs of biliary obstruction
- informed consent
Key exclusion criteria (4 listed)
- age under 18
- Operations like Roux-Y, biliodigestive Anastomosis, BII
- life expectancy less than 3 months
- Karnfosky index less than 60%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
1 secondary outcome
time to stent obstruction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2010.
- Derived from this study: PubMed 25590188Schmidt 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Evaluate Patency of the Viaduct Stent in Comparison to Metal Stents, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karel Caca, Prof. Dr. (+49-7141-9967201, karel.caca@kliniken-lb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01063634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2010.