Laparoscopic versus open parenchymal preserving liver resections in the posterosuperior segments (ORANGE Segments): a multicentre, single-blind, randomised controlled trial
The Lancet Regional Health - Europe, vol. 51, pp. 101228
Abstract
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 (4 days, IQR 3-5 versus 5 days, IQR 4-7; p < 0.001). There were three deaths in the laparoscopic group (3/122 = 2.5%) and one in the open group (1/124 = 0.8%) within 90 days of resection (p = 0.336). Overall postoperative morbidity, severe morbidity, liver-specific morbidity, and readmission were not statistically significant different between the groups. The radical resection (R0) rate in patients with cancer was comparable (laparoscopic 93/106 = 87.7% versus open 97/113 = 85.8%, p = 0.539). Interpretation: For patients with lesions in the posterosuperior segments of the liver, laparoscopic surgery, as compared to open surgery, reduces time to functional recovery. However, this reduction in time to functional recovery did not meet the hypothesized difference in time to functional recovery of two days. Funding: This investigator-initiated trial was funded by Ethicon (Johnson & Johnson), Cancer Research United Kingdom, and Maastricht University Medical Centre+.
Authors 28
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Amsterdam UMC Location University of Amsterdam · Fondazione Poliambulanza Istituto Ospedaliero · Cancer Center Amsterdam
Affiliation as printed
Amsterdam UMC Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands
Cancer Center Amsterdam, Amsterdam, the Netherlands
Department of Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
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University Hospital of Basel · University Hospital Southampton NHS Foundation Trust · Fondazione Poliambulanza Istituto Ospedaliero
Affiliation as printed
Department of Surgery, Clarunis University Digestive Health Care Center Basel, University Hospital Basel, Basel
Department of Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
Hepatobiliary and Pancreatic Surgical Unit, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom
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Vita-Salute San Raffaele University · IRCCS Ospedale San Raffaele
Affiliation as printed
Hepatobiliary Surgery Division, IRCCS San Raffaele Hospital, Milan, Italy
Vita-Salute San Raffaele University, Milano, Italy
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Affiliation as printed
Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, Kortrijk, Belgium
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University Hospitals Birmingham NHS Foundation Trust
Affiliation as printed
Department of Hepatobiliary and Pancreatic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
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Ghent University · Federico II University Hospital
Affiliation as printed
Department of Human Structure and Repair, Ghent University, Ghent, Belgium
Division of HPB, Minimally Invasive and Robotic Surgery, Transplantation Center, Department of Clinical Medicine and Surgery, Federico II University Hospital, Naples, Italy
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Moscow Clinical Scientific Center
Affiliation as printed
Department of Hepato-Pancreato-Biliary Surgery, Moscow Clinical Research Centre, Moscow, Russia
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Maastricht University Medical Centre · Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of General, Visceral and Transplant Surgery, University Hospital RWTH Aachen, Aachen, Germany
Department of Surgery, Maastricht University Medical Centre+, Maastricht, the Netherlands
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Affiliation as printed
Hepatobiliary Surgery Unit, Aintree University Hospital, Liverpool, United Kingdom
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Azienda Ospedaliera San Camillo-Forlanini
Affiliation as printed
Division of General Surgery and Liver Transplantation, San Camillo Hospital, Rome, Italy
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Affiliation as printed
Department of Surgery, Manchester University Foundation Trust, Manchester, United Kingdom
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Affiliation as printed
Institute of Liver Studies, King's College Hospital, London, United Kingdom
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Amsterdam UMC Location University of Amsterdam · Cancer Center Amsterdam
Affiliation as printed
Amsterdam UMC Location University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands
Cancer Center Amsterdam, Amsterdam, the Netherlands
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Oxford University Hospitals NHS Trust
Affiliation as printed
Department of Surgery, Oxford University Hospital NHS Foundation Trust, Oxford, United Kingdom
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Derriford Hospital · University Hospitals Plymouth NHS Trust
Affiliation as printed
Peninsula HPB Unit, Derriford Hospital, University Hospitals Plymouth NHS Trust, Plymouth, United Kingdom
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Affiliation as printed
Hepatobiliary Surgery Division, IRCCS San Raffaele Hospital, Milan, Italy
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Affiliation as printed
Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, Kortrijk, Belgium
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University Hospitals Birmingham NHS Foundation Trust
Affiliation as printed
Department of Hepatobiliary and Pancreatic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
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Fondazione Poliambulanza Istituto Ospedaliero
Affiliation as printed
Department of Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
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Maastricht University Medical Centre · Maastricht University · Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of General, Visceral and Transplant Surgery, University Hospital RWTH Aachen, Aachen, Germany
Department of Surgery, Maastricht University Medical Centre+, Maastricht, the Netherlands
GROW School for Oncology & Reproduction, Maastricht University, 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
Affiliation as printed
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre+, Maastricht, the Netherlands
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Fondazione Poliambulanza Istituto Ospedaliero
Affiliation as printed
Research and Clinical Trials Unit, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
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Maastricht University Medical Centre · Maastricht University · Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of General, Visceral and Transplant Surgery, University Hospital RWTH Aachen, Aachen, Germany
Department of Surgery, Maastricht University Medical Centre+, Maastricht, the Netherlands
GROW School for Oncology & Reproduction, Maastricht University, Maastricht, the Netherlands
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Vita-Salute San Raffaele University · IRCCS Ospedale San Raffaele
Affiliation as printed
Hepatobiliary Surgery Division, IRCCS San Raffaele Hospital, Milan, Italy
Vita-Salute San Raffaele University, Milano, Italy
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Affiliation as printed
Department of Oncology, Addenbrooke's Hospital, Cambridge, United Kingdom
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University Hospital Southampton NHS Foundation Trust · NIHR Southampton Biomedical Research Centre · University of Southampton
Affiliation as printed
University Surgery and Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton/University of Southampton, Southampton, United Kingdom
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Mohammad Abu Hilal corresponding
University of Jordan · University Hospital Southampton NHS Foundation Trust · Fondazione Poliambulanza Istituto Ospedaliero
Affiliation as printed
Department of Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
Department of Surgery, School of Medicine, The University of Jordan, Amman, Jordan
Hepatobiliary and Pancreatic Surgical Unit, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom
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