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Clinical Trials in France / NCT03977779
Recruiting Not applicable

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

NCT03977779 · tracked via the Priya Life Science France tracker
Sponsor
Institut Paoli-Calmettes
Phase
Not applicable
Started
2022-01-20
Last updated
2024-10-24

Condition(s) studied

Obstructive JaundiceBiliary StrictureSphincter of Oddi Dysfunction

Investigational drug(s) / intervention(s)

Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institut Paoli Calmettes Marseille Provence-Alpes-Côte d'Azur Region Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03977779 on ClinicalTrials.gov ↗ ← All trials in France