What effects does radiofrequency have in liver surgeries? Can it help prevent cancer recurrence?
Summary description of the study
Liver cancer is the sixth most common cancer worldwide and the third leading cause of cancer-related death. Furthermore, the liver is also the primary site for metastases from colorectal cancer, which is the third most common malignant disease worldwide. The standard treatment for liver cancer and liver metastases from colorectal cancer is the surgical removal of the tumor-bearing part of the liver. However, after such surgeries, cancer often recurs. Further research is needed to find a solution to this problem. It may help to treat the tumor margins after surgery with a radiofrequency device to reduce the number of tumor recurrences. This method applies high-frequency electromagnetic waves to the tissue at the tumor margins. The device heats the tissue and thereby kills cancer cells that may have remained after surgery. In the study, participants are randomly assigned to two groups. In the experimental group, liver cell cancer or liver metastases are surgically removed and the tumor margins are additionally cauterized using radiofrequency. In the control group, the cancer is only surgically removed. No additional treatment of the tumor margins is performed. Only the study staff will know which group the participants were assigned to. The aim of the study is to determine whether the additional cauterization of the tumor margins with a radiofrequency device can reduce the local recurrence rate of this cancer.
(BASEC)
Intervention under investigation
Surgical removal of liver cell cancer or liver metastases from colon cancer. In the experimental group, the tumor margins are also cauterized using radiofrequency, while in the control group no further treatment of the tumor margins is performed.
(BASEC)
Disease under investigation
Liver cell cancer or liver metastases caused by colon or rectal cancer
(BASEC)
1. Written consent after detailed information about the study 2. 18 years or older 3. WHO Performance Status: 0-2 4. Continuous inclusion of patients (evenly distributed between both sexes) with liver metastases from colorectal cancer or patients with liver cell tumors. 5. Previous chemotherapies are allowed 6. ASA (American Society of Anesthesiology Classification) classification of the patient: 1-3 (BASEC)
Exclusion criteria
1. Previous or concurrent cancers that are not the primary tumor of the liver metastases, except for early-stage cervical cancer, treated skin cancer, or superficial bladder tumors. Cancers successfully treated more than 3 years ago are allowed. 2. ASA (American Society of Anesthesiology Classification) classification of the patient: 4 3. Unresectable metastases outside the liver 4. Liver metastases not originating from colorectal cancer 5. The primary liver tumor must not be benign (BASEC)
Trial sites
Winterthur
(BASEC)
Sponsor
Sponsor: Consorci Mar Parc de Salut de Barcelona ES Sponsor’s representative in Switzerland: Kantonsspital Winterthur
(BASEC)
Contact
Contact Person Switzerland
PD Dr. Dr. med. Lukasz Filip Grochola
+41522664162
lukaszfilip.grochola@clutterksw.chKantonsspital Winterthur
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
22.11.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Unraveling the impact of Radiofrequency in liver surgery: the key to decrease local recurrence? (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
not available