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Procedural data will be recorded from patients with liver metastases from colorectal cancer who have received at least one course of systemic chemotherapy and 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 |
|---|---|---|---|
| Use of NanoKnife System for ablation of metastatic colorectal 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications of IRE: Episode-related complications: | All complications recorded during inpatient stay recorded using Clavien-Dindo and CCI | 30 days |
| Complications of IRE: Intervention for local liver-related complications of IRE |
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Inclusion Criteria:
Exclusion Criteria:
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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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 liver metastases from colorectal cancer in patients who have received systemic chemotherapy.
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Intervention for local liver-related complications of IRE within 12 months of the procedure categorised as radiological, surgical or medical
| 12 months |
| Oncological outcomes: Local progression at site of IRE-treated lesion | Local progression at site of IRE-treated lesion | 12 months |
| Oncological Outcomes: Re-ablation and modality. | Re-ablation and modality. | 12 months |
| Oncological Outcomes: New lesions | Appearance of new lesions in liver, lungs, peritoneum or elsewhere (other) on follow-up. | 12 months |
| Oncological Outcomes: Post IRE Chemotherapy | Any use of chemotherapy after IRE | 12 months |
| Oncological Outcomes: Other liver-directed interventions | Any further liver-directed, anti-cancer intervention including surgery and radiotherapy. | 12 months |
| Oncological Outcomes: Disease-free and overall survival from time of IRE. | Disease-free and overall survival from time of IRE. | 12 months |
| Quality of life - pre procedure | EQ-5D-5L survey | pre procedure up to 7 days |
| Quality of life - 7 days follow-up | EQ-5D-5L survey | 7 days |
| Quality of life - 6 months | EQ-5D-5L survey | 6 months |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
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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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