What effects does radiofrequency have in liver surgeries? Can it help prevent cancer recurrence?
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
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)
Lieu de l’étude
Winterthur
(BASEC)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. Dr. med. Lukasz Filip Grochola
+41522664162
lukaszfilip.grochola@clutterksw.ch(BASEC)
Informations scientifiques
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
22.11.2024
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
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Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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