Risk factors for pancreatic fistula grade C after pancreatoduodenectomy: a large prospective, multicenter Japan-Taiwan collaboration study.

BACKGROUND Grade C postoperative pancreatic fistula (POPF), as defined by International Study Group of Pancreatic Fistula (ISGPF), is the most life-threatening complication after pancreatoduodenectomy (PD). This study aims to evaluate risk factors for Grade C POPF after PD. METHODS This is a prospective, multicenter study based in Japan and Taiwan. Between December 2014 and May 2017, 3,022 patients were enrolled in this study and 2,762 patients were analyzed. We analyzed risk factors of Grade C POPF based on the updated 2016 ISGPF scheme (organ failure, reoperation, and/or death). RESULTS Among 2,762 patients, 46 patients (1.7%) developed Grade C POPF after PD. The mortality rate of the 46 patients with Grade C POPF was 37.0%. On the multivariate analysis, six independent risk factors for Grade C POPF were found; BMI ≥25.0 kg/m2 , chronic steroid use, preoperative serum albumin <3.0 mg/dl, soft pancreas, operative time ≥480 min, and intraoperative transfusion. The c-statistic of our risk scoring model for Grade C POPF using these risk factors was 0.77. The score was significantly higher in Grade C POPF than in Grade B POPF (P<0.001) or none/biochemical leak (P<0.001). CONCLUSIONS This prospective study showed risk factors for Grade C POPF after PD.