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

NCT05492136 | Recruiting DMC

• 1 other identifier: Liveration_v2
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Cancer, Treatment-Related

Outcome Measures

Primary Outcomes (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

  5 years follow-up

Secondary Outcomes (5)

• overall survival (OS)

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

• Disease free survival (DFS)

  2 years of follow-up

• Cancer specific survival (CSS)

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

• Postoperative complications

  90 days after surgery

• Hepatic recurrence

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

Study Arms (2)

Arm 1: Control

NO INTERVENTION

In 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 arm

EXPERIMENTAL

In 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

Procedure: Additional margin coagulation

Interventions

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

Arm 2: study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital del Mar: lead

Study Sites (1)

Hospital del Mar Research Institute

Barcelona, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 41290310 DERIVED

Related Links

• Website

MeSH Terms

Conditions

Liver Neoplasms; Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Patricia Sánchez Velazquez, MD PhD FEBS

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos fuste, MD PhD

CONTACT

0034 932483207; cfuste@imim.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 8, 2022
• Study Start: November 1, 2023
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)