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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous placement of biodegradable biliary stents | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biliary duct patency: bilirubin alterations (> 2.2) | Biliary duct patency after stent implantation evaluating bilirubin alterations | 24 months |
| Stent reabsorption: radiographic persistence of stent radiopaque marks | Radiography | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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120- 150 patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lozano Blesa Universitary Hospital | Zaragoza | Aragon | 50009 | Spain | ||
| Hospital Parc Tauli |
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| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sabadell |
| Barcelona |
| 08208 |
| Spain |