LIVERATION trial: a multicentre European randomised study on radiofrequency margin coagulation and its impact on oncological outcomes after liver surgery – study protocol

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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.

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