Robotic versus laparoscopic hepatectomy for liver malignancies (ROC'N'ROLL): a single-centre, randomised, controlled, single-blinded clinical trial

Abstract

Background: Robotic hepatectomy (RH) has been increasingly adopted for the treatment of liver malignancies despite lacking evidence from randomised trials. We aimed to determine the effect of RH compared to laparoscopic hepatectomy (LH) on quality of life in patients undergoing minimally invasive hepatectomy for liver malignancies.

Methods: This single-blinded, randomised trial was conducted at a tertiary care academic centre (DRKS00027531). Patients with resectable liver malignancies were assessed for eligibility and randomly assigned to either RH or LH with stratification by type of malignancy and difficulty of resection. Patients were blinded to the treatment allocation. The primary outcome was the mean quality of life within 90 days after surgery, measured with the role functioning scale of the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Secondary outcomes included operating time, morbidity, blood loss, conversion rate, postoperative recovery, and resection margin status.

Findings: Between February 21, 2022, and Sep 18, 2023, 80 patients (RH: n = 41, LH: n = 39) were included and analysed on an intention-to-treat basis. Role functioning scores did not differ between RH and LH (mean [SD], 74.3 [23.3] versus 79.6 [22.3]; mean difference -5.3, 95% CI -15.6 to 5.1, p = 0.547). The comprehensive complication index was not significantly different between the study groups (8.9 [23.1] versus 15.5 [23.9], p = 0.137). There were no differences in other perioperative outcomes.

Interpretation: RH yielded similar outcomes in quality of life and can be considered a safe alternative to LH.

Funding: None.

Keywords: DaVinci®; Liver resection; Minimally invasive hepatectomy; Randomized controlled trial; Robot-assisted.

Fig. 1

Patient flow chart.

Fig. 2

Quality of life outcomes. a: The mean change (bars represent mean and 95% CI) in the role functioning scores from baseline according to the QLQ-C30 questionnaire are shown in each treatment arm. There was a significant drop of role functioning scores in each treatment arm at follow-up (−9.0 (−14.9 to −3.1) versus −9.4 (−15.1 to −3.6)). The mean changes were similar in the study groups indicating no treatment effect (p = 0.547, ANCOVA with adjustments for age and baseline role functioning). b: The mean adjusted treatment differences (bars represent mean and 95% CI) of quality of life outcomes according to the QLQ-C30 questionnaire between the study groups are shown (with adjustments for age and baseline quality of life outcomes).

Fig. 3

Surgical outcomes. a: The Comprehensive Complication Index (CCI) stratified by the study groups is displayed (bars represent mean and 95% CI). The unadjusted mean scores [standard deviation] were 8.9 [23.1] versus 15.5 [23.9] in the robotic and laparoscopic hepatectomy group, respectively. There were no significant differences between the study groups (p = 0.137, t-test). RH indicates robotic hepatectomy, LH: laparoscopic hepatectomy. b–d: Time to functional recovery, hospital stay, and days at home are presented in boxplots. No significant differences were detected between the robotic and laparoscopic hepatectomy group for the unadjusted outcomes time to functional recovery, hospital stay, and days at home (Mann–Whitney U test). For each boxplot the solid line indicates median and the box indicates interquartile range. The whiskers denote the range excluding outliers (1.5 interquartile range from the box); outliers are presented as black dots. RH indicates robotic hepatectomy, LH: laparoscopic hepatectomy.