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Clinical Trials in Spain / NCT05492136
Recruiting Not applicable

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

NCT05492136 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2023-11-01
Last updated
2026-07-21

Condition(s) studied

Liver CancerCancer, Treatment-Related

Investigational drug(s) / intervention(s)

Additional margin coagulation

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital del Mar Research Institute Barcelona Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05492136 on ClinicalTrials.gov ↗ ← All trials in Spain