Using a biodegradable stent to prevent pancreatitis after a specific procedure
Prospective Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
This study is testing a new biodegradable stent to see if it can help prevent pancreatitis in patients who are at high risk after a specific procedure called ERCP.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Paoli-Calmettes Academic / other |
| Locations | 1 site (Marseille, Provence-Alpes-Côte d'Azur Region) |
| Trial ID | NCT03977779 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the ARCHIMEDES fast biodegradable pancreatic stent in reducing the incidence and severity of Post-Endoscopic Retrograde CholoangioPancreatography (ERCP) pancreatitis in patients at high risk. The biodegradable stent will be placed during the ERCP procedure, and the study will assess both the efficacy and safety of this intervention. By focusing on patients with specific risk factors, the study aims to provide a targeted approach to preventing complications associated with ERCP.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are at risk of developing pancreatitis due to procedure-related or patient-related factors.
Not a fit: Patients who are pregnant, breastfeeding, or have recently been diagnosed with acute pancreatitis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of pancreatitis in high-risk patients undergoing ERCP.
How similar studies have performed: While the use of biodegradable stents is a novel approach, similar studies have shown promise in reducing complications associated with ERCP.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Marseille, Provence-Alpes-Côte d'Azur Region
- Institut Paoli Calmettes — Marseille, Provence-Alpes-Côte d'Azur Region, France (Recruiting)
Study contacts
- Study coordinator: Dominique Genre, MD
- Email: drci.up@ipc.unicancer.fr
- Phone: +33491223778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.