About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age>18 years
Patients at risk of developing a Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis (procedure and/or patient-related risk factors
Disqualifiers
Pregnant or breastfeeding women
Recent diagnosis (<1 month) of acute pancreatitis
contraindication to endoscopy
Hypersensitivity to indomethacine
Trial design
Single group
Treatments tested in this trial
Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography
DeviceThe ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography
Treatment groups
Trial outcomes
Primary outcomes
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
Sponsors and contacts
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