NCT05492136 Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence?
| NCT ID | NCT05492136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital del Mar |
| Condition | Liver Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 720 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 720 participants in total. It began in 2023-11-01 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Patricia Sánchez Velazquez, MD PhD FEBS
PRINCIPAL INVESTIGATOR
Hospital del Mar
Frequently Asked Questions
Who can join the NCT05492136 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05492136 currently recruiting?
Yes, NCT05492136 is actively recruiting participants. Contact the research team at cfuste@imim.es for enrollment information.
Where is the NCT05492136 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT05492136 clinical trial?
NCT05492136 is sponsored by Hospital del Mar. The principal investigator is Patricia Sánchez Velazquez, MD PhD FEBS at Hospital del Mar. The trial plans to enroll 720 participants.
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