Biliary Stricture, Obstructive Jaundice, Sphincter of Oddi Dysfunction
Conditions
Keywords
biodegradable stent, Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
Brief 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.
Interventions
DEVICEPlacement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography
The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>18 years * Patients at risk of developing a Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis (procedure and/or patient-related risk factors
Exclusion criteria
* Pregnant or breastfeeding women * Recent diagnosis (\<1 month) of acute pancreatitis * contraindication to endoscopy * Hypersensitivity to indomethacine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with a complete clearance of the biodegradable stent | Day 15 | The degradation of the stent will be evaluated both duodenoscopy/fluoroscopy and endoscopy 15 days after its placement |
Countries
France
Contacts
Primary ContactDominique Genre, MD
Backup ContactMarc Giovannini, MD
Outcome results
None listed