LIVERATION آینده جراحی سرطان کبد به روش

Reviewed by Dr Reza Lankarani, General Surgeon

Founder | Surgical Pioneering Newsletter and Podcast Series

Editorial Board Member | Genesis Journal of Surgery and Medicine

- Published online: 13 October 2025

- Citation: Luque Villalobos E et al. BMJ Open 2025;15:e100518.

1. Overview

The LIVERATION trial is a prospective, international, multicentre, single-blind, parallel-group, randomised clinical trial (RCT) funded by the Horizon Europe Programme (Grant 101104360). It aims to determine whether additional margin coagulation (AMC)—using approved radiofrequency (RF) devices (e.g., Coolingbis®, Aquamantys®)—reduces local recurrence (LR) after liver resection for colorectal liver metastases (CRLM) and hepatocellular carcinoma (HCC).

- Design: 1:1 randomisation across 24 centres in 7 European countries.

- Sample size: 698 patients (518 CRLM, 180 HCC), powered to detect absolute reductions in LR of 6.9% (CRLM: 10.2% → 3.3%) and 15.5% (HCC: 20% → 4.5%).

- Primary endpoint: Incidence of LR within 3 years, centrally reviewed on standardized imaging.

- Secondary endpoints: Overall survival (OS), disease-free survival (DFS), cancer-specific survival, complications (Clavien-Dindo/CCI), and quality of life (EORTC QLQ-C30/HCC18).

- Follow-up: 30/90 days, then annually up to 3 years.

- Trial registration: NCT05492136.

The trial builds on earlier retrospective work by the same group, notably Villamonte et al. (2022) , which reported reduced LR with AMC, and Quesada et al. (2017) and Sui et al. (2019) , showing promising signals for RF-assisted transection and Aquamantys®, respectively.

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