Status:
WITHDRAWN
Irreversible Electroporation of Unresectable Liver Tumors
Lead Sponsor:
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
Conditions:
Liver Metastases
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the safety and feasibility of curative intended irreversible electroporation (IRE) in the treatment of liver tumors neighboring major vessels or bile ducts.
Detailed Description
Patients can be included in the study if they have one or more malignant liver tumors unsuitable for resection and thermal ablation (due to proximity of major vessels or bile duct) or other establishe...
Eligibility Criteria
Inclusion
- Primary or secondary cancer of the liver.
- Largest tumor diameter ≤5 cm in any plane.
- Tumor must be deemed as unresectable and unsuitable for other established curative liver directed therapies.
- Treatment must be given with curative intent.
- Patients must be able to give informed consent.
Exclusion
- Radiological signs of synchronous intra- or extrahepatic disease, unless curative intended therapy is planned.
- Tumor is inaccessible e.g. due to venous dilation etc. (assessed with preoperative ultrasound)
- American Society of Anesthesiologists (ASA) score \>3
- Eastern Cooperative Oncology Group (ECOG) performance status \>2
- Child-Pugh class C
- International Normalized Ratio (INR)\>1.5
- Pregnancy
- Persistent atrial fibrillation
- Implanted electronic devices e.g. cardiac pacemakers or other electrostimulators.
- Metal stents or other metallic objects near the ablation zone (unless the stent can be replaced with a plastic stent prior to IRE)
- Severe allergies to anesthetic agent, paralytic agent or any of the equipment used during treatment.
- Patient is referred from a hospital outside of Denmark
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04404647
Start Date
June 1 2020
End Date
March 30 2025
Last Update
March 26 2021
Active Locations (1)
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1
Department of Gastrointestinal Surgery, Aalborg University Hospital
Aalborg, Denmark, 9000