Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05492136

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

Led by Hospital del Mar · Updated on 2025-09-03

720

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent given before surgery with understanding of withdrawal rights
  • Age 18 years or older
  • WHO performance status scale 0 to 2
  • Diagnosed with colorectal liver metastases confirmed by CT, MRI, or biopsy, or with hepatocellular carcinoma
  • Any prior chemotherapy regimen allowed
  • ASA physical status score between 1 and 3
Not Eligible

You will not qualify if you...

  • Previous or other concurrent cancers except certain treated types like cervical carcinoma in situ, basal cell carcinoma, or superficial bladder tumors
  • ASA score of 4
  • Non-resectable metastases outside the liver
  • Liver metastases from non-colorectal cancer origins
  • Benign primary liver tumors
  • Pregnant women
  • Participation in another clinical trial

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital del Mar Research Institute

Barcelona, Spain

Actively Recruiting

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Research Team

C

Carlos fuste, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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