Laparoscopic Hemihepatectomy vs Open Hemihepatectomy Among Patients With Primary or Metastatic Liver Tumors

Results from the ORANGE II PLUS trial demonstrated that a minimally invasive, laparoscopic approach to hemihepatectomy shortened time to functional recovery compared to open, major hemihepatectomy among patients with primary or metastatic liver tumors.

“Surgical resection of the liver is central to the curative treatment strategy of several cancers including colorectal liver metastases, hepatocellular carcinoma, and cholangiocarcinoma,” stated Robert S. Fichtinger, MD, Maastricht University Medical Center, The Netherlands, and coauthors. “Minimally invasive surgery, such as laparoscopy, reduces the physical impact of surgery, accelerates postoperative recovery, and because of the decreased inflammatory response may improve cancer outcomes.”

In this multicenter, patient-blinded trial, 332 patients eligible to undergo left or right hemihepatectomy were randomized on a 1-to-1 basis to undergo either laparoscopic (n = 166; oncological, n = 136) or open (n = 166; oncological, n = 145) resection. The primary end point was time to functional recovery. Key secondary end points included R0 resection margin (≥1 mm), time to adjuvant systemic therapy, and adverse events.

At analysis, median time to functional recovery was 4 days in the laparoscopic arm and 5 days in the open arm (difference, –17.5%; 96% confidence interval [CI], –25.6 to –8.4; P < .001). Conversion from laparoscopic to open resection occurred in 17% of patients due to bleeding (25%) or uncertainty concerning resection margins (75%). The median time to functional recovery was 5 days in those patients. Among oncological patients, R0 resection margin was achieved in 78% of patients in the laparoscopic arm and 84% of patients in the open arm (odds ratio [OR], 0.60; 99% CI, 0.25 to 1.45; P = .14). Time to adjuvant systemic therapy was 46.5 days in the laparoscopic arm and 62.8 days in the open arm (hazard ratio [HR], 2.20; 99% CI, 1.01 to 4.77; P = .009). The incidence of disease recurrence was 49% in the laparoscopic arm and 58% in the open arm (OR, 0.72; 99% CI, 0.38 to 1.37; P = .19).

Major adverse events occurred in 14.5% of patients in the laparoscopic arm and 16.9% of patients in the open arm (OR, 0.84; 99% CI, 0.37 to 1.89; P = .58). Within 90 days of resection, 5 deaths occurred in the laparoscopic arm and 5 deaths occurred in the open arm (OR, 1.02; 99% CI, 0.27 to 3.9; P = .97). Only 1 death in the laparoscopic arm was related to disease progression.

“The laparoscopic approach resulted in a shorter time to functional recovery compared with open surgery… [with] shorter time to adjuvant systemic therapy with no adverse impact on cancer outcomes observed,” concluded Dr Fichtinger et al. 

“This phase III trial adds to the body of evidence supporting a minimally invasive surgical approach over open surgery for major liver resections across a spectrum of primary and metastatic malignancies and with maintenance of oncologic outcomes,” added Journal of Clinical Oncology associate editor Eileen M. O’Reilly, MD, Memorial Sloan Kettering Cancer Center, New York, New York.

Source:

Fichtinger RS, Aldrighetti LA, Abu Hilal M, et al. Laparoscopic versus open hemihepatectomy: The ORANGE II PLUS multicenter randomized controlled trial. J Clin Oncol. Published online: April 19, 2024. doi:10.1200/JCO.23.01019