Abstract
LBA3516 Background: Despite the recent worldwide dissemination of laparoscopic liver surgery, the long-term oncologic outcomes of laparoscopic and open liver surgery have never been compared in a randomized controlled trial. Methods: OSLO-COMET was a randomized controlled trial recruiting patients from Oslo University Hospital, Oslo, Norway. The primary outcome of the trial was postoperative morbidity within 30 days. Patients with radically resectable liver metastases from colorectal cancer were randomly assigned to undergo laparoscopic or open parenchyma-sparing liver resection. Overall survival was a predefined secondary endpoint for the trial. Survival data for the treatment arms will be compared using a log-rank test and Kaplan-Meier plots. Results: From February 2012 to January 2016 a total of 294 patients were screened and 280 (95%) patients were randomized to laparoscopic (n = 133) or open (n = 147) surgery. The primary endpoint demonstrated a significant reduction in morbidity from 31% in the open group to 19% in the laparoscopic group. Other secondary outcomes demonstrated no difference between the groups, including the rate of R0 resection and the width of resection margins, while laparoscopic surgery was found to be cost-effective. Patients received perioperative chemotherapy following Norwegian guidelines. The final patient was operated on Feb 28, 2016, and a survival analysis was performed on March 14, 2019, with a minimum of 36 months follow-up. By ITT analysis (n = 280), median overall survival (OS) was 80 months (95% CI 52-108) in the laparoscopic surgery group and 81 months (95% CI 42-120) in the open surgery group, p=0.91. By modified ITT, (only patients that had R0/R1 resection), median recurrence free survival (RFS) was 19 months (10-27) in the laparoscopic group and 16 months (11-21) in the open group, p = 0.96. Conclusions: Laparoscopic surgery in patients with colorectal liver metastases was associated with rates of OS and RFS similar to open surgery. Clinical trial information: NCT01516710.
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