Clinical trial · Interventional
Percutaneous Irreversible Electroporation to Treat Liver Cancer Close to the Gallbladder
A Prospective Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Unresectable Hepatic Carcinoma Close to the Gallbladder
NCT02332551CI-TRIAL-00053681completedN/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 investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma close to the gallbladder, also Progress Free Survival (PFS) will be recorded.
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 |
|---|---|---|---|
| Hepatic Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NanoKnife | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NanoKnife IRE System
- description
- 90 pulses of 70 microseconds each in duration will be administered per electrode pair
- interventionNames
- Device: NanoKnife
- type
- NO_INTERVENTION
- label
- Control
Primary outcomes (1)
- measure
- Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
- timeFrame
- 30 days (+/- 3 days) post treatment
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria, * Tumor from gallbladder is \<0.5 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 ≤ 7 cm in diameter, * Child-Pugh class A,B * Eastern Cooperative Oncology Group (ECOG) score of 0-1, * American Society of Anaesthesiologists (ASA) score ≤ 3, * 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: * eligible for surgical treatment or transplantation for HCC, * Hepatic carcinoma 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.