WithdrawnNo phase
Irreversible Electroporation of Unresectable Liver Tumors
Key facts
- Who runs it
- Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
- Where
- Denmark1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 1 Jun 2020
- Ended
- 30 Mar 2025
- Type of study
- Interventional
- Treatments tested
- Irreversible electroporation
- Record updated
- 26 March 2021
- Why it stopped
- Low accrual rate
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Metal stents or other metallic objects near the ablation zone (unless the stent can be replaced with a plastic stent prior to IRE)
- Radiological signs of synchronous intra- or extrahepatic disease, unless curative intended therapy is planned
- Implanted electronic devices e.g. cardiac pacemakers or other electrostimulators
- Severe allergies to anesthetic agent, paralytic agent or any of the equipment used during treatment
- International Normalized Ratio (INR)>1.5
- 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
- Pregnancy
- Persistent atrial fibrillation
- Patient is referred from a hospital outside of Denmark
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- InterventionTreatment being tested
Selected patients who choose to participate will undergo ablation of the target lesion using irreversible electroporation.
Treatment: Irreversible electroporation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Irreversible Electroporation of Unresectable Liver Tumors - a Phase I Study of Safety and Feasibility
- Record updated
- 26 March 2021