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

Study acronym: LIVERaTION
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv6
  2. Minor Eligibility criteria shortened, about 74 words
    • Secondary endpoints expanded, about 15 words
    v5
  3. Notable Primary completion date: Dec 31, 2026 to May 31, 2028
    • Study completion date: Dec 31, 2027 to Jun 30, 2028
    v4
  4. Notable Phase: Phase 3 to Not applicable
    • Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 1566 to 720
    • Site details revised
    v3
  5. Notable Start date: Apr 1, 2023 to Nov 1, 2023
    • Study sites: 0 to 1
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05492136
Lead Sponsor Hospital del Mar
Conditions
(from sponsor)
Liver Cancer, Cancer, Treatment-Related
Related terms Liver Neoplasms, Neoplasms, Second Primary
Enrollment 720 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov