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

NCT ID: NCT05492136

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2028-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Arm 1: Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2: study arm

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

Group Type: EXPERIMENTAL

Additional margin coagulation

Intervention Type: 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

Interventions

Additional margin coagulation

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 18 year of age or older.

3. WHO performance scale 0-2

4. 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.

5. Any previous chemotherapy regime is permitted.

6. ASA score 1 to 3.

Exclusion Criteria

1. 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).

2. Any cancer curatively treated > 3 years prior to enrollment is permitted.

3. ASA 4.

4. Non-resectable extrahepatic metastases.

5. Liver metastasis from other origin apart from colorectal.

6. Bening primary tumor of the liver.

7. Pregnant woman.

8. Participation in another clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital del Mar

OTHER

Sponsor Role: lead

Responsible Party

Patricia Sanchez Velazquez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Sánchez Velazquez, MD PhD FEBS

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Locations

Hospital del Mar Research Institute

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Carlos fuste, MD PhD

Role: CONTACT

cfuste@imim.es

0034 932483207

Facility Contacts

Carlos Fuste, MD PhD

Role: primary

cfuste@imim.es

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Related Links

https://liveration.eu

Website

Other Identifiers

Liveration_v2

Identifier Type: -

Identifier Source: org_study_id