Laparoscopic versus open parenchymal preserving liver resections in the posterosuperior segments (ORANGE Segments): a multicentre, single-blind, randomised controlled trial

作者：Jasper P. Sijberden, Christoph Kuemmerli, Francesca Ratti, Mathieu D’Hondt, Robert P. Sutcliffe, Roberto Troisi, Михаил Ефанов, Robert S. Fichtinger, Rafael Díaz-Nieto, Giuseppe Maria Ettorre, Aali J. Sheen, Krishna Menon, Marc G. Besselink, Zahir Soonawalla, Somaiah Aroori, Rebecca Marino, Céline De Meyere, Ravi Marudanayagam, Giuseppe Zimmitti, Bram Olij, Zina Eminton, Lloyd Brandts, Clarissa Ferrari, Ronald M. van Dam, Luca Aldrighetti, S. Pugh, John N. Primrose, Mohammad Abu Hilal · 发表于：The Lancet Regional Health - Europe · 年份：2025 · DOI：10.1016/j.lanepe.2025.101228 · 被引用次数：13 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cholangiocarcinoma and Gallbladder Cancer Studies、Colorectal Cancer Surgical Treatments

Background: An increasing number of liver resections are performed laparoscopically, while laparoscopic resection of lesions in the posterosuperior segments is technically challenging. We aimed to assess the outcomes of laparoscopic and open parenchymal preserving resection of lesions in the posterosuperior segments in a randomised controlled trial. Methods: In this multicentre, patient-blinded, superiority randomised controlled trial, patients requiring parenchymal preserving liver resection for tumours in segment 4a, 7, or 8 were enrolled at 17 centres and randomised 1:1 to laparoscopic or open surgery using a minimisation scheme stratifying for centre and lesion size. The primary endpoint was time to functional recovery measured in postoperative days. To detect a difference in time to functional recovery of two days the sample size needed 250 patients, an interim analysis was planned with 125 patients. Patients and outcome assessors were blinded to the allocation. The study was registered on clinicaltrials.gov, NCT03270917. Findings: Between November 2017 and November 2021, 251 patients were randomised to laparoscopic (n = 125) or open (n = 126) surgery. The majority of patients had a preoperative diagnosis of cancer (225/246 = 91.5%). Time to functional recovery was 3 days (IQR 3-5) in the laparoscopic group compared to 4 days (IQR 3-5) in the open group (difference -19.2%, 96% CI -28.8% to -8.4%; p < 0.001). Hospital stay was similarly shorter in the laparoscopic group (...