LIVERATION PROJECT

LIVERATION: an ambitious, pragmatic multicenter clinical trial in 7 different countries to determine whether additional ablated margin produced by radiofrequency can decrease the recurrence rate of Colorectal Cancer Liver Metastasis (CRLM) and Liver Cancer and improve patient survival.

What is the goal of the LIVERATION Project?

Background

Colorectal Cancer (CRC) ranks fourth in cancer deaths worldwide. Between 20% and 30% of patients with advanced CRC have Liver Metastases (CRLM). Liver cancer ranks second in cancer deaths worldwide, including hepatocellular carcinoma (HCC). Despite recent advances, liver resection offers the only chance of cure for patients with liver metastases and liver cancer.

However, the recurrence rate of these tumours is high even after resection.The presence of positive margins in the remaining liver after resection correlates with increased local recurrence and decreased overall survival, the only factor where prognosis could be influenced by the performance of surgery.

Nevertheless, at present, the extent of a resected margin negative (the margin is free from tumor cells) status remains debatable and varies widely from one publication to another.

Currently, there are radiofrequency ablation studies that, based on preliminary retrospective human clinical trials, are able to correlate an additional coagulation of tumor margins with a reduction on local recurrence. However, there is no prospective and pragmatic controlled study that accurately measures this additional margin and its impact on oncological outcomes. 

The LIVERATION project team

Objectives

Determine whether additional. This whole procedure will be conducted by an ambitious, pragmatic multicenter . 

The aim of LIVERATION is to conduct an ambitious, pragmatic multicenter clinical trial with 720 patients with CRLM and HCC at 24 clinical centres in 7 different countries to determine whether additional ablated margin produced by radiofrequency can decrease the recurrence rate and improve patient survival.

We will also evaluate patients’ quality of life and their experiences throughout the process of the intervention and its comparison with other therapeutic alternatives in terms of quality of life and patient experience in real-world settings.

A multidisciplinary team of internationally recognized research groups, experts in the field of colorectal cancer liver metastasis and patient-centred care, and leading companies supporting the effective development of LIVERATION , a EU Research and Innovation Action.

The LIVERATION project is led and coordinated by surgeons from Institut Hospital del Mar d’Investigacions Mèdiques (IMIM), experts on surgical ablative techniques for CRC and CRLM resection.

The project is backed by the expertise in clinical trial development of the European Clinical Research Infrastructure Network (ECRIN) and its affiliated entities (specially the lead Clinical Trial Unit (CTU) Fundación para la Investigación Biomédica del Hospital Universitario La Paz), and complemented by the expertise on ablative medical devices from Vecmedical.

The project statistical power is provided by the University of Ioanina (UOI), which will also collaborate with the Social Science entities focused on patient experiences evaluation or conducting systematic reviews, SHINE 2Europe (SHINE) and The Avedis Donabedian Research Institute (FAD).

The project will also count with the expertise of the Society for the Improvement of Science (SACSIS), on Communication and Dissemination of the  novelties and results of the LIVERATION project. Liver Patients Asociation (ELPA) to reach the main stakeholders and policy makers.

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