NCT05492136

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Hospital del Mar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cancer
• Cancer, Treatment-Related

Interventions

Type	Name	Description
PROCEDURE	Additional 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

Timeline

• Start date: 2023-11-01
• Primary completion: 2028-05-31
• Completion: 2028-06-30
• First posted: 2022-08-08
• Last updated: 2025-09-03

Locations

1 site across 1 country: Spain