Mesenteric Versus Conventional Approach During Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma (MAPLE-PD trial): A Multicenter Randomized Controlled Trial.

Abstract

This multicenter randomized controlled trial investigated whether the mesenteric approach, which is an infracolic superior mesenteric artery (SMA)-first approach during pancreatoduodenectomy (PD), can improve survival in patients with pancreatic ductal adenocarcinoma (PDAC), compared with the Kocher-first conventional approach. The mesenteric approach might improve surgical outcomes through a nontouch isolation technique for PDAC. This trial was conducted in 24 Japanese high-volume centers. Patients who were scheduled to undergo PD for resectable PDAC or borderline resectable PDAC with portal vein invasion (BR-PV PDAC) were randomly assigned (1:1) via a central web-based application to the conventional or mesenteric approach. The primary endpoint was overall survival (OS). We also analyzed circulating tumor cell (CTC) DNA in the PV blood obtained during surgery. This trial is registered with ClinicalTrials.gov. NCT03317886, and UMIN Clinical Trials UMIN000029615. Between 2018 and 2021, 360 patients were randomly assigned to conventional (n=181) and mesenteric groups (n=179). With a median follow-up of 39.3 months, the median OS was comparable between conventional and mesenteric groups (41.7 vs. 39.3 months; HR 1.02, 95% CI: 0.76-1.37, P =0.897). CTC analysis showed that the mean change in CTC DNA copy number in PV obtained at laparotomy and just before removal of the specimen was significantly different between the conventional (10.1±2.7) and mesenteric (-7.3±2.6) groups ( P <0.001). The mesenteric approach does not improve survival in patients with resectable or BR-PV PDAC, although it might prevent spread of cancer cells via vessels during surgery through the nontouch isolation procedure.