Biodegradable Stent Implantation in Biliary Benign Strictures.
NCT ID: NCT04115696
Last Updated: 2019-10-09
Study Results
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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COMPLETED
150 participants
OBSERVATIONAL
2012-03-01
2019-07-04
Brief Summary
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This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain).
A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).
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Detailed Description
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Patients are recruited when the stent is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24, 36, 48 and 52 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Percutaneous placement of biodegradable biliary stents
The bening biliary strictures stents used in this register are made of polydioxanone (PPDX) (Ella-DV biliary stent, ELLACS, Hradec Králové, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography using the standard micropuncture technique. Before stent implantation, balloon bilioplasty may be performed.
Eligibility Criteria
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Inclusion Criteria
* Informed consent
* Non-lithiasic chronic bening single or multiple stenosis
* Possibility of follow-up plus 1 year
Exclusion Criteria
* Unsigned consent
* Non treatable coagulopathy
* Acute signs of infection
* Diagnosis of neoplasia
18 Years
ALL
No
Sponsors
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Group of Research in Minimally Invasive Techniques
OTHER
Responsible Party
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Locations
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Lozano Blesa Universitary Hospital
Zaragoza, Aragon, Spain
Hospital Parc Tauli
Sabadell, Barcelona, Spain
Countries
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Other Identifiers
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GITMI-03
Identifier Type: -
Identifier Source: org_study_id
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