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Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or plastic stent placement are currently the most popular techniques. Partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. A novel fully covered metallic stent has recently been developed.
The aim of this study was to prospectively evaluate the placement of fully covered self-expandable metallic stents (FCSEMS) in this setting.
After inclusion, an endoscopic procedure (ERCP) was performed in all patients in order to place a FCMS across the benign biliary stricture. The FCMS was left in place for 6 months and then extracted during a second ERCP procedure. An opacification was performed to assess the efficacy of stenting. Patients were followed up during one year after FCMS extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fully covered metal stent (FCMS) | Other | There is one arm in the study : the intervention consists on placing a device which is a fully covered metal stent in the biliary tract of all patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of a FCMS in the biliary tract of the patients | Device | During an ERCP procedure, a fully covered biliary metal stent (FCMS) is placed across a benign biliary stricture |
| Measure | Description | Time Frame |
|---|---|---|
| Initial success rate of temporary FCMS placement | Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Final success | Absence of biliary stricture or the presence of an attenuated stricture and normal liver function tests at the end of follow up. | 18 months |
| Stricture recurrence | Both clinically and ERCP-documented recurrence of stricture after an initial success. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic Prat, MD, PhD | Société Française d'Endoscopie Digestive | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| 18 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |