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The use of an endoprothesis in a pancreatic duct is a measure to minimize the incidence and severity of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis. In this study we will evaluate the use of a Biodegradable Endoprothesis: Archimede Fast Biodegradable Pancreatic Stent in patients with high risk of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis.The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography. The efficacy and the security of the device will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic biodegradable pancreatic stent placement | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography | Device | The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a complete clearance of the biodegradable stent | The degradation of the stent will be evaluated both duodenoscopy/fluoroscopy and endoscopy 15 days after its placement | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Genre, MD | Contact | +33491223778 | drci.up@ipc.unicancer.fr | |
| Marc Giovannini, MD | Contact | giovanninim@ipc.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Calmettes | Recruiting | Marseille | Provence-Alpes-Côte d'Azur Region | 13009 | France |
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| ID | Term |
|---|---|
| D041781 | Jaundice, Obstructive |
| D046628 | Sphincter of Oddi Dysfunction |
| ID | Term |
|---|---|
| D007565 | Jaundice |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D001657 | Biliary Dyskinesia |
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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