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

Not Applicable

Recruiting

• Conditions: Liver Cancer; Cancer, Treatment-Related

• Registration Number: NCT05492136
• Lead Sponsor: Hospital del Mar

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Study Start: 2023-11-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-01
• Last Update Posted: 2025-09-03
• Primary Completion: 2028-05-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Local recurrence	5 years follow-up	Local recurrence (LR): defined as any growing or enhancing tumour in the margin of hepatic resection specifically reviewed to this aim in a later follow-up imaging

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	From the surgery to death or lost of follow-up whichever came first, assessed up to 24 months	defined as time from surgery until death or the end of the study, patients who discontinue from the study without disease will be censored at the time of their last tumour evaluation prior to death or discontinuation.
Disease free survival (DFS)	2 years of follow-up	Disease free survival (DFS), calculated as the time from surgery until disease progression, patients who have not progressed at the time the SVR analysis is performed will be censored at the time of their last tumour evaluation
Cancer specific survival (CSS)	From the surgery to recurrence/last follow-up whichever came first, assessed up to 24 months	Cancer-specific survival (CSS), measured from the date of surgery to the date of death from colorectal cancer/HCC or last follow-up.
Postoperative complications	90 days after surgery	Graded by Clavien-Dindo clasification and CCI
Hepatic recurrence	From the surgery to hepatic recurrence or lost of follow-up whichever came first, assessed up to 24 months	Tumoral recurrence within the liver

Trial Locations

Locations (1)

Hospital del Mar Research Institute; 🇪🇸 Barcelona, Spain