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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital del Mar

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Additional margin coagulation

Treatment groups

720 Participants
are divided into 2 treatment groups

Sponsors and collaborators