RecruitingNot ApplicableNCT05492136

Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence?

Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence? (Study LIVERaTION)


Sponsor

Hospital del Mar

Enrollment

720 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Radiofrequency devices have been increasingly employed in liver surgery in order to achieve proper hemostasis and this use has become more evident with the implementation of minimal invasive surgery. Due to its well-known efficacy for tumor ablation (i.e. hepatocarcinoma) it use has been extended in some cases to ablate the liver surface after resection in questionable resection. Till date, despite the majority of surgeons apply an additional coagulation in doubtful margins, there is not an evidence that this maneuver really decreases the local recurrence or increases the overall survival. On the contrary, some studies have suggested that non-anatomical resections in order to spare liver parenchyma could lead to major zones of liver ischemia in the remnant liver and thus favoring recurrence. However, major liver ischemia (defined as grade 2 o more) is unlikely to be provoked by 1 cm-depth additional coagulation of the margin. The investigators previously published in a retrospective study the concept of additional margin coagulation within liver resections and narrow margins and demonstrated that the study group had significantly less local recurrence compared to the controls. Therefore, in the present study the aim is to continue this evaluation through a multicenter randomized clinical trial.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing outcomes in patients who undergo liver surgery for colorectal cancer that has spread to the liver (CRLM) or primary liver cancer (HCC), with or without the use of radiofrequency energy during the operation. Radiofrequency is sometimes used to help cut through or treat tissue — researchers want to know if it affects local recurrence (cancer coming back near the surgical site). **You may be eligible if...** - You are 18 or older with colorectal cancer that has spread to the liver, or with primary liver cancer (HCC) - Your cancer has been confirmed by CT, MRI, or tissue testing - You are in reasonable health (WHO performance status 0–2, ASA score 1–3) - You are having liver surgery (any prior chemotherapy is allowed) **You may NOT be eligible if...** - You have another active cancer not related to the liver metastases (with certain exceptions for early-stage skin or cervical cancers) - Your liver metastases come from a source other than the colon or rectum - Your cancer cannot be surgically removed - You have very poor general health (ASA 4) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAdditional margin coagulation

After performing the hepatectomy the selected device should be applied onto the surgical margin following the protocol 3-4 s/cm2 of liver transection surface at maximum power output in order to perform an additional margin coagulation


Locations(1)

Hospital del Mar Research Institute

Barcelona, Spain

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NCT05492136


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