Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy (BioSteP)
Pancreatoduodenectomy, Clinically Relevant Postoperative Pancreatic Fistula, Internal Biodegradable Pancreatic Stent
About this trial
This is an interventional prevention trial for Pancreatoduodenectomy focused on measuring Pancreatic surgery, Pancreatoduodenectomy, CR-POPF, Post operative complications, ARCHIMEDES™
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)
Sites / Locations
- IRCCS Ospedale San RaffaeleRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Biodegradable Stent
Non Stent
An internal biodegradable pancreatic stent (ArchimedesTM) will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.
No stent will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.