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Mesenteric Versus Conventional Approach During Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma (MAPLE-PD Trial): A Multicenter Randomised Controlled Trial
40 Pages Posted: 26 Dec 2024
More...Abstract
Background: The mesenteric approach is an infracolic superior mesenteric artery (SMA)-first approach during pancreatoduodenectomy (PD), which might improve surgical outcomes through a non-touch isolation technique for pancreatic ductal adenocarcinoma (PDAC). This study (MAPLE-PD trial) investigated whether the mesenteric approach can improve survival in patients with PDAC compared to the standard Kocher-first conventional approach.
Methods: This multicenter randomised controlled 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 before surgery to the conventional approach or mesenteric approach. The primary endpoint was overall survival (OS). We also analyzed the levels of circulating tumour cell (CTC) DNA in the PV blood obtained during surgery. This trial is registered with ClinicalTrials.gov. NCT03317886, and the University Hospital Medical Information Network Clinical Trials Registry UMIN000029615.
Findings: Between January 2018 and February 2021, 360 patients with resectable or BR-PV PDAC were randomly assigned to a conventional group (n=181) and mesenteric group (n=179). With a median follow-up of 39.3 months (interquartile range: 18.1 to not evaluable), the median OS was comparable between conventional and mesenteric groups (41.7 months [95% confidence interval [CI]: 33.2–47.4] vs. 39.3 months [95% CI: 30.8 to not evaluable]; hazard ratio 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 blood obtained at laparotomy and just before removal of the specimen was significantly different between the conventional group (10.1±2.7) and mesenteric group (-7.3±2.6) (p<0.001).
Interpretation: The mesenteric approach does not improve survival in patients with resectable or BR-PV PDAC, although it might prevent the squeezing of cancer cells during surgery through the non-touch isolation procedure.
Trial Registration: This trial is registered with ClinicalTrials.gov. NCT03317886, and the University Hospital Medical Information Network Clinical Trials Registry UMIN000029615.
Funding: Wakayama Medical University, and Japan Surgical Society Clinical Investigation Project Award.
Declaration of Interest: The authors have no conflicts of interest to declare.
Ethical Approval: The protocol was approved by the Wakayama Medical University Hospital Ethics Committee (Approval No. 2128; Wakayama, Japan).
Keywords: Mesenteric approach, artery-first approach, conventional approach, pancreatoduodenectomy, pancreatic ductal adenocarcinoma, superior mesenteric artery
Suggested Citation: Suggested Citation