Using radiofrequency to reduce liver cancer recurrence after surgery
Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence? (Study LIVERaTION)
This study is testing if using radiofrequency during liver surgery can help prevent liver cancer from coming back and improve survival for patients with questionable surgical margins.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital del Mar Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05492136 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of radiofrequency devices during liver surgery to improve hemostasis and potentially reduce local recurrence of liver cancer. It focuses on the application of additional margin coagulation after tumor resection, particularly in cases where the surgical margins are questionable. The study aims to determine whether this technique can enhance overall survival rates and minimize the risk of recurrence, despite concerns about liver ischemia. Participants will be monitored for outcomes related to their liver cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with liver cancer, specifically those with colorectal metastases or primary liver tumors like hepatocarcinoma, who have not previously undergone local therapy or liver resection.
Not a fit: Patients with prior liver treatments or those with advanced liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced recurrence of liver cancer for patients undergoing surgery.
How similar studies have performed: While some studies have explored the use of radiofrequency in liver surgery, the specific approach of additional margin coagulation remains novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona
- Hospital del Mar Research Institute — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Patricia Sánchez Velazquez, MD PhD FEBS — Hospital del Mar
- Study coordinator: Carlos fuste, MD PhD
- Email: cfuste@imim.es
- Phone: 0034 932483207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.