Periodic Reporting for period 1 - LIVERATION (Unravelling the impact of Radiofrequency in liver surgery: the key to decrease local recurrence?)
Reporting period: 2023-06-01 to 2024-11-30
Colorectal Cancer (CRC) ranks fourth in cancer deaths worldwide. Between 20% and 30% of patients with advanced CRC have Liver Metastases. Liver cancer ranks second in cancer deaths worldwide, including hepatocellular carcinoma. Despite recent advances, liver resection offers the only chance of cure for patients with liver metastases and liver cancer. However, the local recurrence rate of these liver tumours is high even after resection.The presence of positive (with malignant cells) margins in the remaining liver after resection correlates with increased local recurrence and decreased overall survival. So this is the only factor where expectation of survival could be influenced by the performance of surgery.
LIVERATION is an ambitious, pragmatic multicenter clinical trial in 7 different countries and 24 Hospitals to determine whether additional Radiofrequency ablation of tumor margin after liver surgery to resect cancer, can decrease the cancer recurrence rate and improve patient survival. Radiofrequency is a high-frequency alternating polarity, where electrical current is applied to biological tissue as a means to cut, coagulate, desiccate, or fulgurate tissue. Its benefits include the ability to make precise cuts with limited blood loss and its ability to deeply coagulate the tissue. Radiofrequency devices are frequently used during surgical operations helping to prevent blood loss in hospital operating rooms and its indications are being investigated and enlarged each year.
Currently, there are radiofrequency ablation studies that, based on preliminary retrospective human clinical studies, able to correlate an additional coagulation of tumor margins with a reduction on local recurrence. However, there is no prospective and controlled or comparative trial that accurately measures this additional margin and its impact on oncological outcomes. We hope to confirm this expectation with LIVERATION.
LIVERATION is an ambitious, pragmatic multicenter clinical trial in 7 different countries and 24 Hospitals to determine whether additional Radiofrequency ablation of tumor margin after liver surgery to resect cancer, can decrease the cancer recurrence rate and improve patient survival. Radiofrequency is a high-frequency alternating polarity, where electrical current is applied to biological tissue as a means to cut, coagulate, desiccate, or fulgurate tissue. Its benefits include the ability to make precise cuts with limited blood loss and its ability to deeply coagulate the tissue. Radiofrequency devices are frequently used during surgical operations helping to prevent blood loss in hospital operating rooms and its indications are being investigated and enlarged each year.
Currently, there are radiofrequency ablation studies that, based on preliminary retrospective human clinical studies, able to correlate an additional coagulation of tumor margins with a reduction on local recurrence. However, there is no prospective and controlled or comparative trial that accurately measures this additional margin and its impact on oncological outcomes. We hope to confirm this expectation with LIVERATION.
Liveration project started on June 2023. We had the first Kick off meeting with the eight partners and we have initiated the preparation of the clinical trial.
The Consortium has been established, with all partners actively collaborating on their respective work packages and shared tasks.
The clinical trial has successfully received approval from ethics committees in six out of seven countries, as well as from the relevant regulatory agencies. Site agreements, although initially delayed, are progressing in most countries. The Sponsor has actively engaged with Principal Investigators, Clinical Managers, and other key stakeholders to accelerate the signing process. Also the divulgation activities of the project are ongoing, notably the web is done (https://liveration.eu/(opens in new window)) and social media activities in Linkedin are active.
Study is now ongoing with 5 active Hospitals having already patients randomised.
The Consortium has been established, with all partners actively collaborating on their respective work packages and shared tasks.
The clinical trial has successfully received approval from ethics committees in six out of seven countries, as well as from the relevant regulatory agencies. Site agreements, although initially delayed, are progressing in most countries. The Sponsor has actively engaged with Principal Investigators, Clinical Managers, and other key stakeholders to accelerate the signing process. Also the divulgation activities of the project are ongoing, notably the web is done (https://liveration.eu/(opens in new window)) and social media activities in Linkedin are active.
Study is now ongoing with 5 active Hospitals having already patients randomised.
If expectations are confirmed, a reduction of recurrence rate of liver cancer after surgery from 15% to a possible rate of 5% could have a huge impact in patients suffering liver cancer. That could mean 92% of the patients surviving 5 years after liver cancer surgery,
This study is focussed in the confirmation of the surgical technique and the validation of the procedure of additional coagulation of the margin and that procedure can be done with various devices approved and available in the market. So no new intelectual property rights are expected other than the validation of the use of a current and open available technique. It should be added that since the additional margin ablation technique is complex and has several possibilities such as coagulation times and powers of use of the scalpels, we hope that the LIVERATION study will help to refine and determine which technique produces the best results.
This study is focussed in the confirmation of the surgical technique and the validation of the procedure of additional coagulation of the margin and that procedure can be done with various devices approved and available in the market. So no new intelectual property rights are expected other than the validation of the use of a current and open available technique. It should be added that since the additional margin ablation technique is complex and has several possibilities such as coagulation times and powers of use of the scalpels, we hope that the LIVERATION study will help to refine and determine which technique produces the best results.