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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Other: Use of NanoKnife System for ablation of HCC lesions | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irreversible Electroporation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Target Tumour Eradication | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications of IRE: Episode-related complications: | Episode-related complications of IRE using the Clavien-Dindo system and the comprehensive complication index (CCI) | 30 days |
| Complications of IRE: Intervention for local liver-related complications of IRE |
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Inclusion Criteria:
Exclusion Criteria:
General:
Cardiovascular fitness related exclusions:
Tumour-related exclusions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Vanderpoll | Contact | +44 7790921819 | mvanderpoll@angiodynamics.com |
| Name | Affiliation | Role |
|---|---|---|
| Ajith Siriwardena, MD FRCS | Manchester Royal Infirmiary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester Royal Infirmiary | Manchester | M13 9WL | United Kingdom |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
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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
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Any intervention for local liver-related complications of IRE within 12 months of procedure. Interventions will be categorised as radiological, surgical or medical. |
| 12 months |
| Oncological outcomes: Incomplete ablation requiring further intervention | Re-ablation and modality. | 6 months |
| Oncological Outcome: Progression at site of ablation | Appearance of new lesions in liver, lungs, peritoneum or elsewhere (other) on follow-up. | 12 months |
| Oncological outcome: Further anti-cancer intervention | Any further liver-directed, anti-cancer intervention including TACE and SIRT | 12 months |
| Oncological Outcome: Survival (Progression-free & overall) | Progression-free and overall survival at 12 months from time of IRE. | 12 months |
| Oncologic Outcomes: local progression | Local progression at site of IRE-treated lesion. | 12 months |
| Oncologic Outcomes: Chemotherapy post-IRE | Any use of chemotherapy after IRE. | 6 months |
| Quality of life: EQ-5D-5 pre-procedure | Effect of intervention on quality of life as assessed by EQ-5D-5 | within 7 days prior to procedure |
| Quality of life: EQ-5D-5 post-procedure 7 days | Effect of intervention on quality of life as assessed by EQ-5D-5 | 7 days |
| Quality of life: EQ-5D-5 - 6 months | Effect of intervention on quality of life as assessed by EQ-5D-5 | 6 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |