Multinational randomized noninferiority study of minimally invasive versus open pancreatoduedenectomy for resectable neoplasms

Minimally invasive pancreatoduodenectomy (MIPD) might accelerate postoperative recovery in patients with primary resectable neoplasms compared with open pancreatoduodenectomy (OPD), although the safety of MIPD remains debated. A multinational patient-blinded noninferiority study compared MIPD versus OPD. The primary endpoint was overall complications with 90 days of surgery (Comprehensive Complication Index; CCI; range 0-100). The mean CCI was 33.4 ± 27.5 in the MIPD group versus 35.3±25.5 in the OPD group (p=0.002 for noninferiority). In the MIPD group, the time to functional recovery was 7 days (95% CI 6-8), compared with 8 days (7-11) in the OPD group. The MIPD conversion rate to open surgery was 8.4%. Rates of postoperative pancreatic fistula were 22.6% versus 35.7% (RR 0.63; 95% CI 0.43-0.91) and were 12.6% versus 22.7% (0.57; 0.32-0.98) for surgical site infection after MIPD and OPD, respectively. Death by 90 days occurred in 4.7% of patients after MIPD versus 2.0% after OPD (RR 2.40; 95% CI 0,51-11.30). The authors conclude that MIPD was noninferior to OPD for 90-day overall complications.