Hepatocellular Carcinoma (HCC), Liver Ablation, Liver Cancer, Adult
Conditions
Keywords
irreversible electroporation, liver ablation, nanoknife, liver ire registry
Brief summary
Procedural data will be recorded from patients with liver lesions from hepatocellular cancer who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation
Interventions
DEVICEIrreversible Electroporation
Irreversible electroporation (IRE) is a procedure which involves the passage of short intense electrical pulses between probes to destabilize cell membranes by creating nanopores which leads to cell destabilisation and cell death. IRE can be used to selectively damage cancerous cells whilst sparing adjacent supporting connective tissue in vessels and bile ducts allowing a more targeted treatment compared to other types of ablation. IRE also avoids the heat-sink phenomenon which compromises the effectiveness of thermal ablation and possibly reduces the risks of biliary injury.
Sponsors
Angiodynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an international, prospective, multi-centre, registry-based, non-randomized, single arm clinical cohort study of the use of IRE for the treatment of HCC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years and over, able to provide informed consent and with clinical diagnosis of an HCC. Tissue confirmation of HCC prior to treatment is not standard of care and is therefore not required for this study. * Child-Pugh A up to A6. * Eastern Co-operative Oncology Group (ECOG) Score ≤ 2. * Rockwood Frailty Score ≤ 3. * Serum bilirubin \< 30 µmol/L. * Serum creatinine \< 150 µmol/L. * No extrahepatic metastases * IRE can be used for up to 3 tumours \< 3cm in size. Other forms of ablation can be combined with IRE in the same sitting but not for the same lesion. IRE can also be combined with surgical resection.
Exclusion criteria
General: * Patients involved in other research studies. * Patients under the age of 18 years. * Inability to give informed consent. * Patients who are pregnant. * Child-Pugh B or C. * Patients with an ECOG status of \> 2 at time of recruitment. * Rockwood Frailty Score \> 3 * Impaired renal function (serum creatinine \> 150 µmol/L) * Accepted exclusions to IRE from consensus criteria including: * Platelet count \< 50x109 U/L. * International normalised ratio (INR) for blood clotting \> 1.7. * Prior hepatic tumour ablation. Cardiovascular fitness related exclusions: * History of ventricular arrhythmia. * Implanted pacemaker or defibrillator. * Congestive cardiac failure NYHA Class ≥ 3. Tumour-related exclusions: * Tumour ≥ 3 cm in size. * Extrahepatic metastatic disease. * Jaundice (serum bilirubin \> 30 µmol/L). * MDT recommends use of thermal ablation for any given lesion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Tumour Eradication | 6 months | The percentage of target tumours successfully eradicated 6 months after the initial IRE procedure, according to RECIST and PERCIST criteria. This is based on a per-lesion analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications of IRE: Intervention for local liver-related complications of IRE | 12 months | Any intervention for local liver-related complications of IRE within 12 months of procedure. Interventions will be categorised as radiological, surgical or medical. |
| Oncological outcomes: Incomplete ablation requiring further intervention | 6 months | Re-ablation and modality. |
| Oncological Outcome: Progression at site of ablation | 12 months | Appearance of new lesions in liver, lungs, peritoneum or elsewhere (other) on follow-up. |
| Oncological outcome: Further anti-cancer intervention | 12 months | Any further liver-directed, anti-cancer intervention including TACE and SIRT |
| Oncological Outcome: Survival (Progression-free & overall) | 12 months | Progression-free and overall survival at 12 months from time of IRE. |
| Complications of IRE: Episode-related complications: | 30 days | Episode-related complications of IRE using the Clavien-Dindo system and the comprehensive complication index (CCI) |
| Oncologic Outcomes: Chemotherapy post-IRE | 6 months | Any use of chemotherapy after IRE. |
| Quality of life: EQ-5D-5 pre-procedure | within 7 days prior to procedure | Effect of intervention on quality of life as assessed by EQ-5D-5 |
| Quality of life: EQ-5D-5 post-procedure 7 days | 7 days | Effect of intervention on quality of life as assessed by EQ-5D-5 |
| Quality of life: EQ-5D-5 - 6 months | 6 months | Effect of intervention on quality of life as assessed by EQ-5D-5 |
| Oncologic Outcomes: local progression | 12 months | Local progression at site of IRE-treated lesion. |
Countries
United Kingdom
Contacts
Primary ContactMitchell Vanderpoll
Outcome results
None listed