Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy

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 anastomosisarm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosisThe rate of occurrence of CR-POPF will be compared between the two arms.

Inclusion Criteria:Age ≥18Patients who undergo pancreatoduodenectomy (PD)Informed ConsentExclusion Criteria:Previous distal pancreatectomyPatients with intra-operative negligible, intermediate or moderate risk of POPF (fistula risk score < 7)