Effect of Laparoscopic versus Open Distal Pancreatectomy on Recurrence-Free Survival in Patients with Left-sided Pancreatic Cancer: A randomized controlled trial.

Abstract

Objective: The aim of this trial was to evaluate the oncological superiority of laparoscopic versus open distal pancreatectomy in left-sided pancreatic cancer.

Background: The oncological efficacy of laparoscopic distal pancreatectomy in left-sided pancreatic cancer remains controversial.

Methods: We performed a multi-center, open-label, randomized controlled trial of laparoscopic versus open distal pancreatectomy in left-sided pancreatic cancer patients. Candidates were recruited from six centers in China, and randomly assigned to receive either LDP or ODP. The primary outcome was recurrence-free survival, and the secondary outcomes were overall survival, R0 resection rate, and retrieved lymph node numbers.

Results: Of the 481 eligible pancreatic cancer patients between Jan. 9, 2019 and Dec. 8, 2021, 306 candidates were initially enrolled and randomly assigned at 1:1 to receive either LDP or ODP. The last follow-up was performed on Dec. 15, 2023, and 130 patients in the LDP group and 129 patients in the ODP group were included for per-protocol analysis. Median RFS was 15.5 (12.5-18.5) months in the LDP group compared to 15 (9.5-20.5) months in the ODP group (P=0.471). The R0 resection rate in two groups was 88.5% versus 89.1%, respectively. Median retrieved lymph node numbers in two groups were similar (13.5 [10-20] versus 12 [7-17], P=0.165). Complications with a Clavien-Dindo score ≥ 3 occurred in 10 of 130 patients in the LDP group, and 11 of 129 patients in the ODP group.

Conclusion: Although LDP did not provide significant oncological benefits for left-sided pancreatic cancer, it was safe and applicable appropriate. ClinicalTrials.gov NCT03792932.