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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Additional margin coagulation
Procedure/SurgeryAfter 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
Treatment groups
720 Participants
are divided into 2 treatment groupsGroup A: Arm 1: ControlNo intervention 0 interventions
Group B: Arm 2: study armExperimental treatment 1 intervention
Trial outcomes
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
Time frame
5 years follow-upSecondary outcomes
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.
Time frame
From the surgery to death or lost of follow-up whichever came first, assessed up to 24 months2
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
Time frame
2 years of follow-up3
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.
Time frame
From the surgery to recurrence/last follow-up whichever came first, assessed up to 24 months4
Postoperative complications
Graded by Clavien-Dindo clasification and CCI
Time frame
90 days after surgerySponsors and contacts
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Source ClinicalTrials.gov