{
  "abstract": "Introduction Surgical margins are crucial in determining postoperative local recurrence (LR) in patients with colorectal liver metastasis (CRLM) and hepatocellular carcinoma (HCC). Achieving a margin greater than 1 cm can be challenging due to constraints related to remnant liver reserve, proximity to major vascular structures and tumour depth. We previously published findings from a retrospective study suggesting that additional margin coagulation (AMC) using radiofrequency may reduce LR, and this multicentre randomised clinical trial aims to further assess this hypothesis.Methods and analysis The LIVERATION trial is an international, multicentre, single-blind, randomised, parallel-group, controlled clinical trial involving 698 patients undergoing liver resection for CRLM or HCC. Participants will be randomly assigned in a 1:1 ratio to either AMC (study group) or conventional liver resection (control group) to assess oncological outcomes for both CRLM and HCC. The primary outcome is the incidence of LR. Secondary endpoints include overall survival, disease-free survival, cancer-specific survival, surgical complications and quality of life. Follow-ups occur at 30 days, 90 days, and 1, 2 and 3 years postoperatively.Ethics and dissemination The LIVERATION trial has been approved by the Ethics Committee at the sponsor site Hospital del Mar de Barcelona, CEIM-PSMAR (Comité de Ética de la Investigación con Medicamentos – Parc de Salut Mar), as well as by the Institutional Ethics Committees in all participating countries. The results of the main trial, along with each of the secondary endpoints, will be submitted for publication in a peer-reviewed journal. The study adheres to national and international guidelines, including the Declaration of Helsinki, and complies with regulations for studies involving biological samples under Law 14/2007 on Biomedical Research. A dissemination strategy has been developed to engage stakeholders and facilitate knowledge transfer to support the use of the findings of the study. LIVERATION is funded by the European Union under the Horizon Europe Framework Programme (Project Number: 101104360).Trial registration number NCT05492136.",
  "authors": [
    {
      "affiliations": [
        "Department of HBP Surgery, Hospital del Mar, Barcelona, Catalunya, Spain",
        "Hospital del Mar Research Institute IMIM, Barcelona, Catalunya, Spain",
        "Universitat Pompeu Fabra, Barcelona, Catalunya, Spain"
      ],
      "name": "Eduardo Luque Villalobos"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Hospital del Mar, Barcelona, Catalunya, Spain",
        "Hospital del Mar Research Institute IMIM, Barcelona, Catalunya, Spain",
        "Universitat Pompeu Fabra, Barcelona, Catalunya, Spain"
      ],
      "name": "Benedetto Ielpo"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, IRCCS Ospedale San Raffaele, Milan, Lombardy, Italy"
      ],
      "name": "Luca Aldrighetti"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Fondazione PTV Policlinico Tor Vergata, Roma, Lazio, Italy"
      ],
      "name": "Alessandro Anselmo"
    },
    {
      "affiliations": [
        "Department of HBP Surgery and Liver Transplantation, Beaujon Hospital, Assistance Publique Hôpitaux de Paris, University of Paris Cité, Clichy, Île-de-France, France"
      ],
      "name": "Nassiba Beghdadi"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, San Camillo Forlanini Hospital, Roma, Lazio, Italy"
      ],
      "name": "Giammauro Berardi"
    },
    {
      "affiliations": [
        "Department of HBP Surgery and Liver Transplantation, Hospital Universitario Reina Sofia, Córdoba, Andalucía, Spain"
      ],
      "name": "Francisco Briceño"
    },
    {
      "affiliations": [
        "Department of HBP Surgery and Liver Transplantation, Hospital Universitario Reina Sofia, Córdoba, Andalucía, Spain"
      ],
      "name": "Ruben Ciria"
    },
    {
      "affiliations": [
        "Liver, Biliary and Pancreatic Unit. Department of General and Digestive Surgery, Hospital Clinico Universitario of Valencia. Department of Surgery. University of Valencia. Biomedical Research Institute, INCLIVA, Valencia, Spain"
      ],
      "name": "Dimitri Dorcaratto"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Norbert Barlicki Memorial University Hospital, Medical University of Lodz, Lodz, Poland"
      ],
      "name": "Adam Durczynski"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, San Camillo Forlanini Hospital, Roma, Lazio, Italy"
      ],
      "name": "Giuseppe Maria Ettorre"
    },
    {
      "affiliations": [
        "Unit of Hepato-Biliary and Pancreatic Surgery, “F. Miulli” General Hospital, 70021 Acquaviva delle Fonti, Bari, Italy",
        "Department of Medicine and Surgery, LUM University, 70010 Casamassima, Bari, Italy"
      ],
      "name": "Antonella Delvecchio"
    },
    {
      "affiliations": [
        "Service of General and Digestive Surgery, Sanchinarro University Hospital, Clara Campal Oncological Center, Health Sciences Faculty, HM Hospitals. Carrillo José Cela University, Madrid, Community of Madrid, Spain"
      ],
      "name": "Valentina Ferri"
    },
    {
      "affiliations": [
        "Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Warsaw, Poland"
      ],
      "name": "Michał Grąt"
    },
    {
      "affiliations": [
        "Liver, Biliary and Pancreatic Unit. Department of General and Digestive Surgery, Hospital Clinico Universitario of Valencia. Department of Surgery. University of Valencia. Biomedical Research Institute, INCLIVA, Valencia, Spain"
      ],
      "name": "Marina Garces-Albir"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Kantonsspital Winterthur, Winterthur, Zurich, Switzerland"
      ],
      "name": "Lukasz Filip Grochola"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Norbert Barlicki Memorial University Hospital, Medical University of Lodz, Lodz, Poland"
      ],
      "name": "Piotr Hogendorf"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Campania, Italy"
      ],
      "name": "Francesco Izzo"
    },
    {
      "affiliations": [
        "Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Warsaw, Poland"
      ],
      "name": "Konrad Kobryn"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Metaxa Cancer Hospital of Piraeus, Piraeus, Attika, Greece"
      ],
      "name": "Elissaios Kontis"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Agios Savvas General Cancer and Oncology Hospital of Athens, Athens, Attica, Greece"
      ],
      "name": "Dimitris Korkolis"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Medical University of Silesia in Katowice, Department of General, Vascular and Transplant Surgery, Katowice, Silesian Voivodeship, Poland"
      ],
      "name": "Robert Król"
    },
    {
      "affiliations": [
        "Department of HBP Surgery and Liver Transplantation, Beaujon Hospital, Assistance Publique Hôpitaux de Paris, University of Paris Cité, Clichy, Île-de-France, France"
      ],
      "name": "Mickael Lesurtel"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Hospital Universitari de Girona Doctor Josep Trueta, Girona, Catalunya, Spain"
      ],
      "name": "Santiago Lopez-Ben"
    },
    {
      "affiliations": [
        "Department of Primary Education, University of Ioannina, Ioannina, Greece"
      ],
      "name": "Christos Christogiannis"
    },
    {
      "affiliations": [
        "Department of Primary Education, University of Ioannina, Ioannina, Greece"
      ],
      "name": "Ourania Koutsiouroumpa"
    },
    {
      "affiliations": [
        "Department of Primary Education, University of Ioannina, Ioannina, Greece"
      ],
      "name": "Dimitris Mavridis"
    },
    {
      "affiliations": [
        "Unit of Hepato-Biliary and Pancreatic Surgery, “F. Miulli” General Hospital, 70021 Acquaviva delle Fonti, Bari, Italy",
        "Department of Medicine and Surgery, LUM University, 70010 Casamassima, Bari, Italy"
      ],
      "name": "Riccardo Memeo"
    },
    {
      "affiliations": [
        "Department of General Surgery and Surgical Oncology",
        "Chair of Surgical Oncology, The Regional Hospital in Poznan –The Greater Poland Specialist Center",
        "Collegium Medicum, University of Zielona Góra, Poznań, Zielona Gora, Poland"
      ],
      "name": "Dawid Murawa"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, National and Kapodistrian University of Athens General Hospital of Athens Laiko, Athens, Attica, Greece"
      ],
      "name": "Nikolaos Machairas"
    },
    {
      "affiliations": [
        "Liver, Biliary and Pancreatic Unit. Department of General and Digestive Surgery, Hospital Clinico Universitario of Valencia. Department of Surgery. University of Valencia. Biomedical Research Institute, INCLIVA, Valencia, Spain"
      ],
      "name": "Isabel Mora-Oliver"
    },
    {
      "affiliations": [
        "Liver, Biliary and Pancreatic Unit. Department of General and Digestive Surgery, Hospital Clinico Universitario of Valencia. Department of Surgery. University of Valencia. Biomedical Research Institute, INCLIVA, Valencia, Spain"
      ],
      "name": "Elena Muñoz-Forner"
    },
    {
      "affiliations": [
        "Avedis Donabedian Instituto Universitario UAB, Barcelona, Spain",
        "Universitat Autònoma de Barcelona, Barcelona, Spain",
        "Research Network on Chronicity Primary Care and Prevention and Health Promotion, Madrid, Spain"
      ],
      "name": "Carola Orrego"
    },
    {
      "affiliations": [
        "Shine 2Europe, Coimbra, Portugal"
      ],
      "name": "Carina Dantas"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Hospital del Mar, Barcelona, Catalunya, Spain",
        "Hospital del Mar Research Institute IMIM, Barcelona, Catalunya, Spain",
        "Universitat Pompeu Fabra, Barcelona, Catalunya, Spain"
      ],
      "name": "Carlos Fuste"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Hospital del Mar, Barcelona, Catalunya, Spain"
      ],
      "name": "Alberto García Picazo"
    },
    {
      "affiliations": [
        "University Hospital of Strasbourg, Department of HBP Surgery, Nouvel Hopital Civil, Strasbourg, France"
      ],
      "name": "Patrick Pessaux"
    },
    {
      "affiliations": [
        "Department of General Surgery and Surgical Oncology",
        "Chair of Surgical Oncology, The Regional Hospital in Poznan –The Greater Poland Specialist Center",
        "Collegium Medicum, University of Zielona Góra, Poznań, Zielona Gora, Poland"
      ],
      "name": "Tomasz Pilat"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Paul Brousse Hospital, Villejuif, Île-de-France, France"
      ],
      "name": "Gabriella Pittau"
    },
    {
      "affiliations": [
        "Department of Radiology, Hospital del Mar, Barcelona, Catalunya, Spain"
      ],
      "name": "Aleksandar Radosevic"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, IRCCS Ospedale San Raffaele, Milan, Lombardy, Italy"
      ],
      "name": "Francesca Ratti"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, National and Kapodistrian University of Athens General Hospital of Athens Laiko, Athens, Attica, Greece"
      ],
      "name": "Georgios Sotiropoulos"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, General Hospital of Athens Ippokrateio, Athens, Attica, Greece"
      ],
      "name": "Konstantinos Toutouzas"
    },
    {
      "affiliations": [
        "Department of Abdominal Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia"
      ],
      "name": "Blaz Trotovsek"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Medical University of Silesia in Katowice, Department of General, Vascular and Transplant Surgery, Katowice, Silesian Voivodeship, Poland"
      ],
      "name": "Wojciech Wystrychowski"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, General University Hospital of Larissa, Larissa, Thessaly, Greece"
      ],
      "name": "Dimitris Zacharoulis"
    },
    {
      "affiliations": [
        "Service of General and Digestive Surgery, Sanchinarro University Hospital, Clara Campal Oncological Center, Health Sciences Faculty, HM Hospitals. Carrillo José Cela University, Madrid, Community of Madrid, Spain"
      ],
      "name": "Emilio Vicente"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Hospital del Mar, Barcelona, Catalunya, Spain",
        "Hospital del Mar Research Institute IMIM, Barcelona, Catalunya, Spain",
        "Universitat Pompeu Fabra, Barcelona, Catalunya, Spain"
      ],
      "name": "Fernando Burdio"
    },
    {
      "affiliations": [
        "Department of HBP Surgery, Hospital del Mar, Barcelona, Catalunya, Spain",
        "Hospital del Mar Research Institute IMIM, Barcelona, Catalunya, Spain",
        "Universitat Pompeu Fabra, Barcelona, Catalunya, Spain"
      ],
      "name": "Patricia Sánchez Velázquez"
    }
  ],
  "title": "LIVERATION trial: a multicentre European randomised study on radiofrequency margin coagulation and its impact on oncological outcomes after liver surgery – study protocol",
  "uid": "3d42082d-bc74-5c8e-9c3e-a4d012d055c5"
}