Clinical trial · Interventional
Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma
Studio Clinico Pilota Con Uso di Elettroporazione Irreversibile (IRE) Nel Trattamento di Lesioni Neoplastiche Epatiche Con Localizzazione ad accessibilità Limitata o ad Alto Rischio
NCT01442324CI-TRIAL-00007462unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.
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 |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Neoplasm Metastasis | Liver Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible electroporation (IRE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IRE
- description
- Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.
- interventionNames
- Procedure: Irreversible electroporation (IRE)
Primary outcomes (1)
- measure
- Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma.
- timeFrame
- 1 month post-intervention
- description
- The primary measurement parameter for the purposes of this determination is the evaluation of the response of IRE treated lesions according to modified RECIST criteria using CT images or magnetic resonance imaging performed 20 to 40 days after treatment.
Secondary outcomes (2)
- measure
- Safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * older than 18 years, * male or female, * diagnosis of secondary liver cancer or cholangiocarcinoma based on positive biopsy or noninvasive criteria, * presence of at least one lesion untreatable by surgical resection or ablation for microwave or radio frequency, * the target nodule must have a diameter of ≤ 5 cm * ECOG score(Eastern Cooperative Oncology Group) 0, * ASA score (American Society of Anesthesiologists) ≤ 3, * prothrombin time ratio \>50% * platelet count \>50x10\^9/l, * patient's ability to discontinue anticoagulant and antiplatelet therapy for seven days before and seven days after surgery with NanoKnife™, * ability to understand and willingness to sign the written informed consent form (ICF), * life expectancy of at least 3 months. Exclusion Criteria: * presence of more than 5 liver lesions, * previous treatment of the target nodule, * patient received systemic chemotherapy within 30 days of treatment with the IRE NanoKnife™, * heart failure, coronary artery disease or arrhythmia in progress, active implantable devices (eg pacemaker), * pregnant women or women of childbearing potential not using an acceptable method of contraception, * patient undergoing treatment with an investigational drug within 30 days of treatment with the IRE NanoKnife™, * in the opinion of the researcher, anyone who can not follow the calendar of visits and assessments of the Protocol.
References
Publications (4)
- BACKGROUNDBall C, Thomson KR, Kavnoudias H. Irreversible electroporation: a new challenge in "out of operating theater" anesthesia. Anesth Analg. 2010 May 1;110(5):1305-9. doi: 10.1213/ANE.0b013e3181d27b30. Epub 2010 Feb 8. PMID 20142349
- BACKGROUNDOnik G, Mikus P, Rubinsky B. Irreversible electroporation: implications for prostate ablation. Technol Cancer Res Treat. 2007 Aug;6(4):295-300. doi: 10.1177/153303460700600405. PMID 17668936
- BACKGROUNDEsser AT, Smith KC, Gowrishankar TR, Weaver JC. Towards solid tumor treatment by irreversible electroporation: intrinsic redistribution of fields and currents in tissue. Technol Cancer Res Treat. 2007 Aug;6(4):261-74. doi: 10.1177/153303460700600402. PMID 17668933
- BACKGROUNDAl-Sakere B, Andre F, Bernat C, Connault E, Opolon P, Davalos RV, Rubinsky B, Mir LM. Tumor ablation with irreversible electroporation. PLoS One. 2007 Nov 7;2(11):e1135. doi: 10.1371/journal.pone.0001135. PMID 17989772