Laparoscopic Versus Open Hemihepatectomy: The ORANGE II PLUS Multicenter Randomized Controlled Trial
Journal of Clinical Oncology, vol. 42, pp. 1799–1809
Abstract
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 < .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 < .001) and body image (difference, 0.9 points; P < .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.
Authors 53
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Maastricht University Medical Centre · Maastricht University · Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany
Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands
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Affiliation as printed
Hepatobiliary Surgery Division, IRCCS San Raffaele Hospital, Milan, Italy
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University Hospital Southampton NHS Foundation Trust · Fondazione Poliambulanza Istituto Ospedaliero
Affiliation as printed
Department of Surgery, Poliambulanza Hospital, Brescia, Italy
Department of Surgery, Southampton University Hospital NHS Foundation Trust, Southampton, United Kingdom
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Ghent University Hospital · Federico II University Hospital · University of Naples Federico II
Affiliation as printed
Department of General, Hepatobiliary and Liver Transplantation Surgery, Ghent University Hospital, Ghent, Belgium
Division of HPB, Minimally Invasive and Robotic Surgery, Department of Clinical Medicine and Surgery, Transplantation Service, Federico II University, Naples, Italy
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University Hospitals Birmingham NHS Foundation Trust
Affiliation as printed
Department of Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
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Amsterdam UMC Location University of Amsterdam · Cancer Center Amsterdam
Affiliation as printed
Cancer Center Amsterdam, the Netherlands
Department of Surgery, Amsterdam UMC, Location University of Amsterdam, Amsterdam, the Netherlands
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Plymouth Hospital · University Hospitals Plymouth NHS Trust
Affiliation as printed
Department of Surgery, Plymouth Hospitals NHS Trust, Plymouth, United Kingdom
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King's College Hospital NHS Foundation Trust · King's College Hospital
Affiliation as printed
Department of Surgery, King's College Hospital NHS Foundation Trust, London, United Kingdom
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Oslo University Hospital · University of Oslo
Affiliation as printed
Intervention Center and Department of Hepatic, Pancreatic and Biliary Surgery, Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway
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Affiliation as printed
Department of Digestive and Hepatobiliary/Pancreatic Surgery, AZ Groeninge, Kortrijk, Belgium
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Affiliation as printed
Department of Digestive Surgery, Unit of Hepatobiliary Surgery and Transplantation, Hôpitaux Universitaires de Bruxelles, Hôpital Erasme, Brussels, Belgium
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Maastricht University Medical Centre · Maastricht University · Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany
Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands
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Aintree University Hospitals NHS Foundation Trust · Aintree University Hospital
Affiliation as printed
Department of Hepato-Biliary Surgery, Aintree University Hospital NHS Foundation Trust, Liverpool, United Kingdom
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University of Oxford · Oxford University Hospitals NHS Trust
Affiliation as printed
Department of Surgery, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom
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Newcastle upon Tyne Hospitals NHS Foundation Trust
Affiliation as printed
Department of Surgery, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, United Kingdom
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Affiliation as printed
Department of Digestive and Hepatobiliary/Pancreatic Surgery, Jessa Hospital, Hasselt, Belgium
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Maastricht University Medical Centre · Maastricht University · Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany
Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands
GROW—School for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands
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Affiliation as printed
Hepatobiliary Surgery Division, IRCCS San Raffaele Hospital, Milan, Italy
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University Hospital Southampton NHS Foundation Trust
Affiliation as printed
Department of Surgery, Southampton University Hospital NHS Foundation Trust, Southampton, United Kingdom
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Affiliation as printed
Department of General, Hepatobiliary and Liver Transplantation Surgery, Ghent University Hospital, Ghent, Belgium
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Affiliation as printed
Department of General, Hepatobiliary and Liver Transplantation Surgery, Ghent University Hospital, Ghent, Belgium
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Affiliation as printed
Department of Surgery, Free University Hospital, AZ Jette Hospital, Brussels, Belgium
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University Hospitals Birmingham NHS Foundation Trust
Affiliation as printed
Department of Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
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Amsterdam UMC Location University of Amsterdam · Cancer Center Amsterdam
Affiliation as printed
Cancer Center Amsterdam, the Netherlands
Department of Surgery, Amsterdam UMC, Location University of Amsterdam, Amsterdam, the Netherlands
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Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands
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Maastricht University Medical Centre · Maastricht University · Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Deceased
Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany
Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands
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Affiliation as printed
Southampton Clinical Trials Unit, University of Southampton, Southampton, United Kingdom
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Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, the Netherlands
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Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, the Netherlands
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Maastricht University Medical Centre · Maastricht University · Essen University Hospital · Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany
Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands
Department of Surgery, University Hospital Essen, Essen, Germany
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Oslo University Hospital · University of Oslo
Affiliation as printed
Intervention Center and Department of Hepatic, Pancreatic and Biliary Surgery, Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway
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Affiliation as printed
Department of Oncology, Addenbrooke's Hospital, Cambridge, United Kingdom
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Maastricht University · Care and Public Health Research Institute
Affiliation as printed
Department of Methodology and Statistics, CAPHRI Care and Public Health Research Institute Maastricht University, Maastricht, the Netherlands
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University Hospital Southampton NHS Foundation Trust
Affiliation as printed
Department of Surgery, Southampton University Hospital NHS Foundation Trust, Southampton, United Kingdom
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Maastricht University Medical Centre · Maastricht University · Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany
Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands
GROW—School for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands
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Aintree University Hospitals NHS Foundation Trust · Aintree University Hospital
Affiliation as printed
Department of Hepato-Biliary Surgery, Aintree University Hospital NHS Foundation Trust, Liverpool, United Kingdom
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Amsterdam UMC Location University of Amsterdam · Cancer Center Amsterdam
Affiliation as printed
Cancer Center Amsterdam, the Netherlands
Department of Surgery, Amsterdam UMC, Location University of Amsterdam, Amsterdam, the Netherlands
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University Hospitals Birmingham NHS Foundation Trust
Affiliation as printed
Department of Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
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Affiliation as printed
Department of Digestive Surgery, Unit of Hepatobiliary Surgery and Transplantation, Hôpitaux Universitaires de Bruxelles, Hôpital Erasme, Brussels, Belgium
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Ghent University Hospital · Federico II University Hospital · University of Naples Federico II
Affiliation as printed
Department of General, Hepatobiliary and Liver Transplantation Surgery, Ghent University Hospital, Ghent, Belgium
Division of HPB, Minimally Invasive and Robotic Surgery, Department of Clinical Medicine and Surgery, Transplantation Service, Federico II University, Naples, Italy
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Affiliation as printed
Department of Digestive and Hepatobiliary/Pancreatic Surgery, Jessa Hospital, Hasselt, Belgium
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King's College Hospital NHS Foundation Trust · King's College Hospital
Affiliation as printed
Department of Surgery, King's College Hospital NHS Foundation Trust, London, United Kingdom
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Maastricht University Medical Centre · Maastricht University · Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany
Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands
GROW—School for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands
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Oslo University Hospital · University of Oslo
Affiliation as printed
Intervention Center and Department of Hepatic, Pancreatic and Biliary Surgery, Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway
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University of Oxford · Oxford University Hospitals NHS Trust
Affiliation as printed
Department of Surgery, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom
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Plymouth Hospital · University Hospitals Plymouth NHS Trust
Affiliation as printed
Department of Surgery, Plymouth Hospitals NHS Trust, Plymouth, United Kingdom
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University Hospital Southampton NHS Foundation Trust
Affiliation as printed
Department of Surgery, Southampton University Hospital NHS Foundation Trust, Southampton, United Kingdom
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Affiliation as printed
Southampton Clinical Trials Unit, University of Southampton, Southampton, United Kingdom
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