NCT03977779

Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis

Prospective Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obstructive Jaundice
• Biliary Stricture
• Sphincter of Oddi Dysfunction

Interventions

Type	Name	Description
DEVICE	Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography	The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography

Timeline

• Start date: 2022-01-20
• Primary completion: 2024-12-01
• Completion: 2024-12-15
• First posted: 2019-06-06
• Last updated: 2024-10-24

Locations

1 site across 1 country: France