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

Liver Cancer Clinical Trial

— LIVERaTION  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05492136
• Other study ID #: Liveration_v2
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2023
• Source: Hospital del Mar
• Contact: Carlos fuste, MD PhD
• Phone: 0034 932483207
• Email: cfuste[@]imim.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1566
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (see appendix 1)

4. Patients suffering from liver metastases of colorectal origin confirmed either by abdominal CT, abdominal MRI or/and by histologic-cytological evaluation.

5. Patients suffering from primary liver tumor such as Hepatocarcinoma

6. Patients suffering from other extra-liver metastases when they are assumed to be curable at any moment are allowed to join the trial (e.g. lung metastases that are amenable to be resected at any moment).

7. Patients should not have been previously treated by either local therapy or resection in the liver (naïve for local or resection approach of the liver).

8. Any previous chemotherapy regime is permitted.

9. ASA (American Society of Anesthesiology classification) of the patient: 1 to 3

Exclusion Criteria:

1. Previous or concurrent cancer that is distinct from one primary tumor of which the LM come 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.

2. ASA 4

3. Non-resectable extrahepatic metastases

4. Liver metastasis from other origin apart from colorectal

5. Any condition that in the opinion of the investigator may interfere evaluation of the study results.

Related Conditions & MeSH terms

• Cancer, Treatment-Related
• Liver Cancer
• Neoplasms, Second Primary
• Recurrence

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Spain	Hospital del Mar Research Institute	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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