Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence?
Recruiting now · Not applicable
Conditions studied: Liver Cancer, Cancer, Treatment-Related
In brief
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.
Key facts
- Study ID
- NCT05492136
- Run by
- Hospital del Mar
- People needed
- 720
- Starts
- 2023-11-01
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
- 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.
- 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.
Where it is running
- Hospital del Mar Research Institute — Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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