Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial
Christoph Kuemmerli,
Robert S. Fichtinger,
Alma Moekotte,
Luca A. Aldrighetti,
Somaiah Aroori,
Marc G. H. Besselink,
Mathieu D’Hondt,
Rafael Díaz-Nieto,
Bjørn Edwin,
Mikhail Efanov,
Giuseppe M. Ettorre,
Krishna V. Menon,
Aali J. Sheen,
Zahir Soonawalla,
Robert Sutcliffe,
Roberto I. Troisi,
Steven A. White,
Lloyd Brandts,
Gerard J. P. van Breukelen,
Jasper Sijberden,
Siân A. Pugh,
Zina Eminton,
John N. Primrose,
Ronald van Dam,
Mohammed Abu Hilal,
on behalf of the ORANGE trials collaborative
Affiliations
Christoph Kuemmerli
Hepatobiliary and Pancreatic Surgical Unit, University Hospital Southampton NHS Foundation Trust
Robert S. Fichtinger
Department of Surgery, Maastricht University Medical Centre+
Alma Moekotte
Hepatobiliary and Pancreatic Surgical Unit, University Hospital Southampton NHS Foundation Trust
Luca A. Aldrighetti
Hepatobiliary Surgery Division, IRCCS San Raffaele Hospital
Somaiah Aroori
Peninsula HPB Unit, Derriford Hospital, Plymouth Hospitals NHS Trust
Marc G. H. Besselink
Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam
Mathieu D’Hondt
Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital
Rafael Díaz-Nieto
Hepatobiliary Surgery Unit, Aintree University Hospital
Bjørn Edwin
Department of HPB Surgery, Oslo University Hospital
Mikhail Efanov
Department of Hepato-Pancreato-Biliary Surgery, Moscow Clinical Research Centre
Giuseppe M. Ettorre
Division of General Surgery and Liver Transplantation, San Camillo Hospital
Krishna V. Menon
Institute of Liver Studies, Kings College Hospital
Aali J. Sheen
Department of Surgery, Manchester University Foundation Trust
Zahir Soonawalla
Department of Surgery, Oxford University Hospital NHS Foundation Trust
Robert Sutcliffe
Department of Hepatobiliary and Pancreatic Surgery, University Hospitals Birmingham, NHS Foundation Trust
Roberto I. Troisi
Division of HPB, Minimally Invasive and Robotic Surgery, Department of Clinical Medicine and Surgery, Federico II University Hospital
Steven A. White
Department of HPB and Transplant Surgery, Freeman Hospital
Lloyd Brandts
Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht UMC+
Gerard J. P. van Breukelen
Department of Methodology and Statistics, Maastricht University Medical Centre
Jasper Sijberden
Department of Surgery, Foundation Poliambulanza
Siân A. Pugh
Department of Oncology, Addenbrooke’s Hospital
Zina Eminton
Southampton Clinical Trials Unit, University of Southampton
John N. Primrose
Department of Surgery, University of Southampton
Ronald van Dam
Department of Surgery, Maastricht University Medical Centre+
Mohammed Abu Hilal
Hepatobiliary and Pancreatic Surgical Unit, University Hospital Southampton NHS Foundation Trust
Abstract Background A shift towards parenchymal-sparing liver resections in open and laparoscopic surgery emerged in the last few years. Laparoscopic liver resection is technically feasible and safe, and consensus guidelines acknowledge the laparoscopic approach in the posterosuperior segments. Lesions situated in these segments are considered the most challenging for the laparoscopic approach. The aim of this trial is to compare the postoperative time to functional recovery, complications, oncological safety, quality of life, survival and costs after laparoscopic versus open parenchymal-sparing liver resections in the posterosuperior liver segments within an enhanced recovery setting. Methods The ORANGE Segments trial is an international multicentre randomised controlled superiority trial conducted in centres experienced in laparoscopic liver resection. Eligible patients for minor resections in the posterosuperior segments will be randomised in a 1:1 ratio to undergo laparoscopic or open resections in an enhanced recovery setting. Patients and ward personnel are blinded to the treatment allocation until postoperative day 4 using a large abdominal dressing. The primary endpoint is time to functional recovery. Secondary endpoints include intraoperative outcomes, length of stay, resection margin, postoperative complications, 90-day mortality, time to adjuvant chemotherapy initiation, quality of life and overall survival. Laparoscopic liver surgery of the posterosuperior segments is hypothesised to reduce time to functional recovery by 2 days in comparison with open surgery. With a power of 80% and alpha of 0.04 to adjust for interim analysis halfway the trial, a total of 250 patients are required to be randomised. Discussion The ORANGE Segments trial is the first multicentre international randomised controlled study to compare short- and long-term surgical and oncological outcomes of laparoscopic and open resections in the posterosuperior segments within an enhanced recovery programme. Trial registration ClinicalTrials.gov NCT03270917 . Registered on September 1, 2017. Before start of inclusion. Protocol version: version 12, May 9, 2017
