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| Name | Class |
|---|---|
| Universitat Autonoma de Barcelona | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous placement of biodegradable biliary stents | Device | Benign biliary strictures treated with polydioxanone (PPDX) stents (Ella-DV biliary stent, ELLACS, Hradec KrƔlovƩ, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography. Before stent implantation, balloon bilioplasty is be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Primary Patency | Time until new intervention due to re-stenosis or occlusion (detected by clinical signs and symptoms and confirmed by blood-test disturbances and/or imaging tests) | Time from stent implantation to new intervention due to restenosis or occlusion detected by clinical signs and symptoms and confirmed by blood-test disturbances and/or imaging tests), assessed up to 60 months |
| Adverse Events | Major and minor complications. The Clavien-Dindo classification will be used for grading the severity of complications. | From stent implantation to completion of follow-up, up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | To correctly deploy a biodegradable stent using a percutaneous approach covering the stricture with a residual stenosis of less than 30% of the lumen, and correct flow of contrast through it into the intestinal lumen | Immediate (during procedure) |
| Length of Hospital Stay |
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Inclusion Criteria:
Exclusion Criteria:
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50 patients with symptomatic benign biliary strictures from Parc Tauli University Hospital referral area and derived from other referring Hospitals treated in our center with a BBS
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| Name | Affiliation | Role |
|---|---|---|
| Eva Criado-Paredes, MD | Corporació Universitaria Parc Tauli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Parc Tauli Sabadell | Sabadell | 08208 | Spain |
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number of days that patients spend in hospital to have the stent inserted, including a 24-48h control cholangiogram |
| nights from admission to perform the stent implantation to discharge of the patient from the hospital, assessed up to 365 days |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D041781 | Jaundice, Obstructive |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D007565 | Jaundice |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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