STUDIO PROSPETTICO MULTICENTRICO SULLA GESTIONE DEI DRENAGGI DOPO DUODENOCEFALOPANCREASECTOMIA UTILIZZANDO UN SISTEMA DI STRATIFICAZIONE DEL RISCHIO

Objective: This multicenter study sought to prospectively evaluate a drain management protocol for pancreatoduodenectomy (PD). Background: Recent evidence suggests value for both selective drain placement and early drain removal for PD. Both strategies have been associated with reduced rates of clinically relevant pancreatic fistula (CR-POPF) – the most common and morbid complication following PD. Methods: The protocol was applied to 260 consecutive PDs performed at two institutions over 17 months. Risk for ISGPF CR-POPF was determined intra-operatively using the Fistula Risk Score (FRS); drains were omitted in negligible/low risk patients and drain fluid amylase (DFA) was measured on POD1 for moderate/high risk patients. Early drain removal (POD3) occurred for patients with POD1 DFA ≤5000 U/L, while patients with POD1 DFA >5000 U/L were managed by clinical discretion. Outcomes were compared with a historical cohort (N=557; 2011-2014). Results: Fistula risk did not differ between cohorts (Median FRS: 4 vs. 4; p=0.933). No CR-POPFs developed in the 70 (29.4%) negligible/low risk patients. Overall CR-POPF rates were significantly lower following protocol implementation (11.2 vs 20.6%, p=0.001). The protocol cohort also demonstrated lower rates of severe complications, any complication, reoperation, and percutaneous drainage (all p<0.05). These patients also experienced reduced hospital stay (8 vs. 9 days, p=0.001). There were no differences between cohorts in bile or chyle leaks. Conclusion: Drains can be safely obviated for one-quarter of PDs. Drain amylase analysis identifies which moderate/high risk patients benefit from early drain removal. This data-driven, risk-stratified approach has significantly decreased the occurrence of clinically relevant pancreatic fistula.