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NCT Number: NCT05492136

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

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.

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Key information

Conditions

Liver Cancer Cancer, Treatment-Related Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Neoplasms, Second Primary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar Research Institute

Barcelona, Spain

Location status: Recruiting

Location contact

Benedetto Ielpo, MD PhD

SUB_INVESTIGATOR

Carlos Fuste, MD PhD

CONTACT

[email protected]

Fernando Burdío, MD PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent granted prior to the initiation of the surgical procedure, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  • 18 year of age or older.
  • WHO performance scale 0-2
  • Consecutive patients (both sexes equally distributed) suffering from CRLM confirmed either by abdominal CT, abdominal MRI or/and by histologic-cytological evaluation or patients suffering from HCC.
  • Any previous chemotherapy regime is permitted.
  • ASA score 1 to 3.

Exclusion criteria

  • Previous or concurrent cancer that is distinct from one primary tumor of which the Liver metastasis comes from EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1).
  • Any cancer curatively treated > 3 years prior to enrollment is permitted.
  • ASA 4.
  • Non-resectable extrahepatic metastases.
  • Liver metastasis from other origin apart from colorectal.
  • Bening primary tumor of the liver.
  • Pregnant woman.
  • Participation in another clinical trial.

Treatment and study plan

Additional margin coagulation

Procedure

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

Primary outcomes

  1. Local recurrence

    Time frame: 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 outcomes

  1. overall survival (OS)

    Time frame: 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.

  2. Disease free survival (DFS)

    Time frame: 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

  3. Cancer specific survival (CSS)

    Time frame: 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.

  4. Postoperative complications

    Time frame: 90 days after surgery

    Graded by Clavien-Dindo clasification and CCI

  5. Hepatic recurrence

    Time frame: From the surgery to hepatic recurrence or lost of follow-up whichever came first, assessed up to 24 months

    Tumoral recurrence within the liver

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos fuste, MD PhD

CONTACT

[email protected]

0034 932483207

Sponsors and collaborators

Lead sponsor

Hospital del Mar

Other

Registry information

Official study title

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

Acronym: LIVERaTION

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 8, 2022
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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