Biodegradable Stent Implantation in Biliary Benign Strictures.

NCT ID: NCT04115696

Last Updated: 2019-10-09

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

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-01

Study Completion Date

2019-07-04

Brief Summary

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Spanish registry of resorbable stent implantation in biliary benign strictures.

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).

Detailed Description

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This is an prospective observational study of patients that have been implanted a biodegradable stent in the biliary tree.

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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Biliary Tract Biliary Tract Diseases Stenosis Follow-Up Studies Stents

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years-old
* Informed consent
* Non-lithiasic chronic bening single or multiple stenosis
* Possibility of follow-up plus 1 year

Exclusion Criteria

* Under 18 years old
* Unsigned consent
* Non treatable coagulopathy
* Acute signs of infection
* Diagnosis of neoplasia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Group of Research in Minimally Invasive Techniques

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lozano Blesa Universitary Hospital

Zaragoza, Aragon, Spain

Site Status

Hospital Parc Tauli

Sabadell, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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GITMI-03

Identifier Type: -

Identifier Source: org_study_id

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