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NCT03977779 Clinical Trial

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

Biliary Stricture Clinical Trial

— ARCHIMEDE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03977779
Other study ID # ARCHIMEDE-PANCREAS-IPC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 20, 2022
Est. completion date September 5, 2022

Study information
Verified date March 2022
Source Institut Paoli-Calmettes
Contact Dominique Genre, MD
Phone +33491223778
Email drci.up@ipc.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 46
Est. completion date September 5, 2022
Est. primary completion date July 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Institut Paoli Calmettes Marseille Provence-Alpes-Côte d'Azur

Sponsors (1)
Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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