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Liver CancerLIVERaTIONNCT05492136

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

A study testing Additional margin coagulation in people with Liver Cancer and Cancer, Treatment-Related, run by Hospital del Mar at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cancer, Cancer, Treatment-Related
What is being tested?
Additional margin coagulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
1 siteSpain
Study dates
1 Nov 2023to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carlos fuste, MD PhD contact

0034 932483207

cfuste@imim.es

Spain1 site, 1 recruiting

  • Hospital del Mar Research Institute

    Barcelona

    Carlos Fuste, MD PhD, cfuste@imim.es

    Fernando Burdío, MD PhD

    Recruiting

Other trials in Spain

About this study

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

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.

Being tested
Additional margin coagulation
Medical subject headings
Liver Neoplasms, Neoplasms, Second Primary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Additional margin coagulationProcedure or surgery

    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

Study groups in NCT05492136
Study groupRoleWhat they receive
Arm 1: ControlNo interventionIn this arm it will be permitted one/several conventional methods according to surgeon preference: * Conventional crusch-clamp or finger fracture technique * Ultrasonic dissector (CUSA, SONOK..) or Ultrasonic mediated devices * Water jet dissector * Argon beam coagulator
Arm 2: study armExperimentalIn this arm it will be permitted to use the radiofrequency devices which have demonstrated evidence in the literature in terms of reducing local recurrence alone or in combination with any conventional method described previously in Arm. (Coolingbis device by VecMedical as well as Aquamantys (Medtronic) These devices and their operating procedure have been described in detail elsewhere Briefly, it consists of a handheld instrument that might be employed not only for margin coagulation but also as hemostatic instrument. After performing the hepatectomy the bladeless part of the 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
Receives: Procedure: Additional margin coagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local recurrence

    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

    Measured: 5 years follow-up

Secondary outcomes (5)

  1. overall survival (OS)

    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.

    Measured: From the surgery to death or lost of follow-up whichever came first, assessed up to 24 months

  2. Disease free survival (DFS)

    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

    Measured: 2 years of follow-up

  3. Cancer specific survival (CSS)

    Cancer-specific survival (CSS), measured from the date of surgery to the date of death from colorectal cancer/HCC or last follow-up.

    Measured: From the surgery to recurrence/last follow-up whichever came first, assessed up to 24 months

  4. Postoperative complications

    Graded by Clavien-Dindo clasification and CCI

    Measured: 90 days after surgery

  5. Hepatic recurrence

    Tumoral recurrence within the liver

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2022
  2. Study start1 Nov 2023
  3. Primary completion31 May 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
720 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05492136
Sponsor's protocol ID
Liveration_v2
Acronym
LIVERaTION
Status last verified
Jul 2026
First submitted
3 Aug 2022
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Luque Villalobos E, Ielpo B, Aldrighetti L, Anselmo A, Beghdadi N, Berardi G, Briceno F, Ciria R, Dorcaratto D, Durczynski A, Ettorre GM, Delvecchio A, Ferri V, Grat M, Garces-Albir M, Grochola LF, Hogendorf P, Izzo F, Kobryn K, Kontis E, Korkolis D, Krol R, Lesurtel M, Lopez-Ben S, Christogiannis C, Koutsiouroumpa O, Mavridis D, Memeo R, Murawa D, Machairas N, Mora-Oliver I, Munoz-Forner E, Orrego C, Dantas C, Fuste C, Garcia Picazo A, Pessaux P, Pilat T, Pittau G, Radosevic A, Ratti F, Sotiropoulos G, Toutouzas K, Trotovsek B, Wystrychowski W, Zacharoulis D, Vicente E, Burdio F, Sanchez Velazquez P. LIVERATION trial: a multicentre European randomised study on radiofrequency margin coagulation and its impact on oncological outcomes after liver surgery - study protocol. BMJ Open. 2025 Nov 24;15(11):e100518. doi: 10.1136/bmjopen-2025-100518.

    PubMed 41290310

Questions about this trial

What is this clinical trial studying?

A study testing Additional margin coagulation in people with Liver Cancer and Cancer, Treatment-Related, run by Hospital del Mar at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carlos fuste, MD PhD (0034 932483207, cfuste@imim.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local recurrence (time frame: 5 years follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05492136, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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