Clinical trial · Interventional
Percutaneous Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome
Comparison Percutaneous Cryosurgery and Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome
NCT02329106CI-TRIAL-00053699completedN/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)
The purpose of this study is to evaluate the safety and efficacy of irreversible electroportion in unresectable liver cancer close to diaphragmatic dome.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible electroporation (IRE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NanoKnife LEDC System
- description
- Ablation with the NanoKnife Low Energy Direct Current (LEDC) System, alao called Irreversible electroporation (IRE), 90 pulses of 70 microseconds each in duration will be administered per electrode pair.
- interventionNames
- Device: Irreversible electroporation (IRE)
- type
- NO_INTERVENTION
- label
- Control
- description
- The patients without treatment
Primary outcomes (1)
- measure
- Evaluate the safety of IRE for unresectable liver cancer close to diaphragmatic dome using Common terminology Criteria for Adverse Events (CTCAE).
- timeFrame
- up to 7 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Liver cancer diagnosed by positive biopsy or non-invasive criteria, * Tumors from diaphragm is \<1 cm * not suitable for surgical resection or transplantation, * have at least one, but less than or equal to 3 tumors, * of the tumour(s) identified, each tumor must be ≤ 5 cm in diameter, * Child-Pugh class A,B * Eastern Cooperative Oncology Group (ECOG) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x109/L, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure, * are able to comprehend and willing to sign the written informed consent form (ICF), * have a life expectancy of at least 3 months. Exclusion Criteria: * liver cancer developed on an already transplanted liver, * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg Pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, * are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
References
Publications (0)
Data not yet available
No reference posted for this study.