NCT05668260 Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy
| NCT ID | NCT05668260 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ospedale San Raffaele |
| Condition | Pancreatoduodenectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 122 participants |
| Start Date | 2023-01-25 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 122 participants in total. It began in 2023-01-25 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (PD), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (CR-POPF). Patients undergoing PD will be randomized into two arms: * arm 1: a biodegradable internal pancreatic stent will be placed at the level of the pancreatic anastomosis * arm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosis The rate of occurrence of CR-POPF will be compared between the two arms.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05668260 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatoduodenectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05668260 currently recruiting?
Yes, NCT05668260 is actively recruiting participants. Contact the research team at falconi.massimo@hsr.it for enrollment information.
Where is the NCT05668260 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05668260 clinical trial?
NCT05668260 is sponsored by Ospedale San Raffaele. The trial plans to enroll 122 participants.