Clinical trial · Interventional
Irreversible Electroporation of Unresectable Liver Tumors
Irreversible Electroporation of Unresectable Liver Tumors - a Phase I Study of Safety and Feasibility
NCT04404647CI-TRIAL-00050899withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Metastases | Bile Duct Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible electroporation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Selected patients who choose to participate will undergo ablation of the target lesion using irreversible electroporation.
- interventionNames
- Procedure: Irreversible electroporation
Primary outcomes (1)
- measure
- 90-day complication rate and severity
- timeFrame
- 90 days after intervention (last patient)
- description
- Adverse events will be registered and scaled according to the Clavien-Dindo classification.
Secondary outcomes (9)
- measure
- Technical success rate
- timeFrame
- 90 days after intervention (last patient)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.