Actively Recruiting
Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy
Led by Ospedale San Raffaele · Updated on 2025-03-14
122
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
Sponsors
O
Ospedale San Raffaele
Lead Sponsor
A
amg International
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60;18 years
- Patients undergoing pancreatoduodenectomy (PD)
- Provided informed consent to participate in the study
You will not qualify if you...
- Previous distal pancreatectomy
- Patients with negligible, intermediate, or moderate risk of postoperative pancreatic fistula (Fistula Risk Score < 7)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Milan, Italy, 20132
Actively Recruiting
Research Team
M
Massimo Falconi, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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