Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial
Authors: Robert S. Fichtinger, Luca A. Aldrighetti, Mohammed Abu Hilal, Roberto I. Troisi, Robert P. Sutcliffe, Marc G. Besselink, Somaiah Aroori, Krishna V. Menon, Bjørn Edwin, Mathieu D'Hondt, Valerio Lucidi, Tom F. Ulmer, Rafael Díaz-Nieto, Zahir Soonawalla, Steve White, Gregory Sergeant, Bram Olij, Francesca Ratti, Christoph Kuemmerli, Vincenzo Scuderi, Frederik Berrevoet, Aude Vanlander, Ravi Marudanayagam, Pieter Tanis, Maxime J.L. Dewulf, Cornelis H.C. Dejong, Zina Eminton, Merel L. Kimman, Lloyd Brandts, Ulf P. Neumann, Åsmund A. Fretland, Siân A. Pugh, Gerard J.P. van Breukelen, John N. Primrose, Ronald M. van Dam, Ulf Neumann, Florian Ulmer, Finja Clausen, Rafael Díaz-Nieto, Michelle Lintforth, Marc Besselink, Pieter Tanis, Burak Gorçek, Marcel van der Poel, Robert Sutcliffe, Ravi Marudanayagam, Penelope Rogers, Valerio Lucidi, Viviane van Laethem, Roberto Troisi, Frederik Berrevoet, Vincenzo Scuderi, Aude Vanlander, Betsy van Loo, Kathleen Segers, Gregory Sergeant, Mathieu D'Hondt, Celine Demeyere, Krishna Menon, Ane Zamalloa, Ronald van Dam, Cornelis Dejong, Maxime Dewulf, Lloyd Brandts, Robert Fichtinger, Bram Olij, Merel Kimman, Gerard van Breukelen, Luca Aldrighetti, Francesca Ratti, Steve White, Stuart Robinson, Caroline Brunton, Björn Edwin, Åsmund Fretland, Davit Aghayan, Zahir Soonawalla, Katherine Gordon-Quayle, Somaiah Aroori, Tracy Ward, John Primrose, Mohammed Abu Hilal, Christopher Kümmerli, Jess Boxal, Zina Eminton
Journal: Journal of Clinical Oncology (2024)

PURPOSE To compare outcomes after laparoscopic versus open major liver resection (hemihepatectomy) mainly for primary or metastatic cancer. The primary outcome measure was time to functional recovery. Secondary outcomes included morbidity, quality of life (QoL), and for those with cancer, resection margin status and time to adjuvant systemic therapy. PATIENTS AND METHODS This was a multicenter, randomized controlled, patient-blinded, superiority trial on adult patients undergoing hemihepatectomy. Patients were recruited from 16 hospitals in Europe between November 2013 and December 2018. RESULTS Of the 352 randomly assigned patients, 332 patients (94.3%) underwent surgery (laparoscopic, n = 166 and open, n = 166) and comprised the analysis population. The median time to functional recovery was 4 days (IQR, 3-5; range, 1-30) for laparoscopic hemihepatectomy versus 5 days (IQR, 4-6; range, 1-33) for open hemihepatectomy (difference, –17.5% [96% CI, –25.6 to –8.4]; P &lt; .001). There was no difference in major complications (laparoscopic 24/166 [14.5%] v open 28/166 [16.9%]; odds ratio [OR], 0.84; P = .58). Regarding QoL, both global health status (difference, 3.2 points; P &lt; .001) and body image (difference, 0.9 points; P &lt; .001) scored significantly higher in the laparoscopic group. For the 281 (84.6%) patients with cancer, R0 resection margin status was similar (laparoscopic 106 [77.9%] v open 122 patients [84.1%], OR, 0.60; P = .14) with a shorter time to adjuvant systemic therapy in the laparoscopic group (46.5 days v 62.8 days, hazard ratio, 2.20; P = .009). CONCLUSION Among patients undergoing hemihepatectomy, the laparoscopic approach resulted in a shorter time to functional recovery compared with open surgery. In addition, it was associated with a better QoL, and in patients with cancer, a shorter time to adjuvant systemic therapy with no adverse impact on cancer outcomes observed.