Comparing biodegradable stents to no stents in high-risk pancreatic surgery patients
Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy (BioSteP): a Randomized Controlled Study
This study is testing whether using a biodegradable stent during pancreatic surgery can help prevent complications like pancreatic leaks in high-risk patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan, Milan) |
| Trial ID | NCT05668260 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of a biodegradable internal pancreatic stent in preventing clinically relevant postoperative pancreatic fistula (CR-POPF) in patients undergoing pancreatoduodenectomy (PD). Participants will be randomly assigned to receive either the biodegradable stent or no stent at the pancreatic anastomosis site. The study will focus on comparing the rates of CR-POPF between the two groups, utilizing the Fistula Risk Score to determine eligibility. The novel ARCHIMEDES™ stent is designed to minimize the risk of displacement, potentially improving patient outcomes after surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing pancreatoduodenectomy and are at high risk for developing postoperative pancreatic fistula.
Not a fit: Patients with a low to moderate risk of developing pancreatic fistula or those who have had previous distal pancreatectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative complications in high-risk pancreatic surgery patients.
How similar studies have performed: While the use of pancreatic stents has been explored in previous studies, the specific application of the biodegradable ARCHIMEDES™ stent represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 * Patients who undergo pancreatoduodenectomy (PD) * Informed Consent Exclusion Criteria: * Previous distal pancreatectomy * Patients with intra-operative negligible, intermediate or moderate risk of POPF (fistula risk score \< 7)
Where this trial is running
Milan, Milan
- IRCCS Ospedale San Raffaele — Milan, Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Massimo Falconi, Professor
- Email: falconi.massimo@hsr.it
- Phone: 0039 022643 6046
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.