Using a pancreatic stent to reduce pancreatitis risk after a specific procedure
Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?
This study tests if putting a stent in the pancreas can help prevent pancreatitis in patients who have a tough time with a certain procedure called ERCP.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 268 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT04408482 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether the placement of a prophylactic pancreatic stent can reduce the risk of post-endoscopic pancreatitis after pancreatic sphincterotomy in patients who experience difficult cannulation. It compares outcomes between patients who receive the stent and those who do not. The study focuses on patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) for common bile duct cannulation. The definition of difficult cannulation is based on established literature criteria.
Who should consider this trial
Good fit: Ideal candidates are adults presenting with naïve papilla requiring ERCP for common bile duct cannulation.
Not a fit: Patients under 18 years old, those with acute pancreatitis, or those who do not consent to the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly lower the incidence of pancreatitis in patients undergoing ERCP.
How similar studies have performed: Other studies have explored similar interventions, but the specific use of pancreatic stents in this context is less common and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive patients with naïve papilla presenting to ERCP with indication of common bile duct (CBD) cannulation will be considered to the study. Exclusion Criteria: * Exclusion criteria are age below 18 years, acute pancreatitis and no consent to the study.
Where this trial is running
Helsinki
- Helsinki Univeristy Hospital — Helsinki, Finland (Recruiting)
Study contacts
- Study coordinator: Andrea Tenca, MD, PhD
- Email: ante14@hotmail.it
- Phone: +358408484955
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.