Trials / Completed
CompletedNCT05556668
Percutaneous Biodegradable Biliary Stents for the Treatment of Benign Biliary Strictures.
Role of Biodegradable Polydioxanone Biliary Stents for the Percutaneous Treatment of Benign Biliary Strictures.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Corporacion Parc Tauli · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess safety and effectiveness in the long term of percutaneous insertion of Biodegradable (BD) Biliary Stents for the treatment of benign biliary strictures, in a single center experience.
Detailed description
This is an observational study (retrospective analysis on a prospective database) of patients that have been implanted a biodegradable stent in the biliary tree to treat benign stenosis. From march 2011 until May 2020, a prospective collection of clinical data has been conducted in patients with symptomatic benign biliary strictures treated biodegradable polydioxanone stents. A strict follow-up protocol has been carried out according to standard practice (at 2, 4, 6 months and every 6 months up to 5 years). Once the follow-up is completed, the collected data will be analyzed, assessing the long term effectiveness and safety, but also other variables related to stent implantation and impact on patient's quality of life. A subgroup analysis of anastomotic biliary strictures will be performed.
Conditions
- Biliary Stricture
- Biliary Tract Diseases
- Bile Duct Stricture
- Bile Duct Injury
- Stents
- Obstructive Jaundice
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Percutaneous placement of biodegradable biliary stents | Benign biliary strictures treated with polydioxanone (PPDX) stents (Ella-DV biliary stent, ELLACS, Hradec Králové, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography. Before stent implantation, balloon bilioplasty is be performed. |
Timeline
- Start date
- 2022-08-20
- Primary completion
- 2022-11-05
- Completion
- 2022-12-20
- First posted
- 2022-09-27
- Last updated
- 2023-03-01
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05556668. Inclusion in this directory is not an endorsement.