Minimally Invasive versus Open Pancreatoduodenectomy for Resectable Neoplasms

作者：Nine de Graaf, Anouk M. L. H. Emmen, Marco Ramera, Jony van Hilst, Bergþór Björnsson, Ugo Boggi, C.L. Bruna, Olivier R. Busch, Freek Daams, Daphne Droogh, Giovanni Ferrari, Sebastiaan Festen, Martina Guerra, Ignace H. J. T. de Hingh, Tobias Keck, Bas Groot Koerkamp, Daan J. Lips, Misha Luyer, J. Sven D. Mieog, Luca Morelli, I. Quintus Molenaar, Roeland F. de Wilde, Mahsoem Ali, Clarissa Ferrari, Johannes Berkhof, Patrick Maisonneuve, Mohammad Abu Hilal, Marc G. Besselink · 发表于：NEJM Evidence · 年份：2025 · DOI：10.1056/evidoa2500045 · 被引用次数：27 · 研究领域：Pancreatic and Hepatic Oncology Research、Cholangiocarcinoma and Gallbladder Cancer Studies、Pancreatitis Pathology and Treatment

BACKGROUND: Minimally invasive pancreatoduodenectomy (MIPD) might accelerate postoperative recovery in patients with primary resectable neoplasm compared with open pancreatoduodenectomy (OPD), although the safety of MIPD remains debated. We aimed to assess whether MIPD is noninferior to OPD for overall complications and superior for time to functional recovery (TTFR). METHODS: We conducted an international, multicenter, patient-blinded randomized noninferiority trial in patients undergoing pancreatoduodenectomy for primary resectable pancreatic and periampullary neoplasm from high-volume centers. Patients were randomly assigned in a 2:1 ratio to undergo robot-assisted or laparoscopic MIPD versus OPD and were blinded to the procedure until postoperative day 5. The primary end point was overall complications within 90 days of surgery, as measured using the Comprehensive Complication Index (range 0-100, with higher scores indicating more severe complications). Noninferiority was tested using a margin of -7.5 points (one-sided 97.5% confidence interval [CI]; P<0.025 for noninferiority). The main secondary end point was TTFR, tested for superiority. Analyses were reported by the intention-to-treat principle. RESULTS: Overall, 288 patients were randomly assigned (190 MIPD [170 robot-assisted, 20 laparoscopic] and 98 OPD) in 14 centers. The mean Comprehensive Complication Index was 33.4±27.5 in the MIPD group versus 35.3±25.5 in the OPD group (mean difference, -1.9; 95% CI, -8.5 to ...