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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Manchester Royal Infirmiary
Manchester, United Kingdom
Target Tumour Eradication
The percentage of target tumours successfully eradicated 6 months after the initial IRE procedure, according to RECIST and PERCIST criteria.
Time frame: 6 months
Complications of IRE: Episode-related complications:
All complications recorded during inpatient stay recorded using Clavien-Dindo and CCI
Time frame: 30 days
Complications of IRE: Intervention for local liver-related complications of IRE
Intervention for local liver-related complications of IRE within 12 months of the procedure categorised as radiological, surgical or medical
Time frame: 12 months
Oncological outcomes: Local progression at site of IRE-treated lesion
Local progression at site of IRE-treated lesion
Time frame: 12 months
Oncological Outcomes: Re-ablation and modality.
Re-ablation and modality.
Time frame: 12 months
Oncological Outcomes: New lesions
Appearance of new lesions in liver, lungs, peritoneum or elsewhere (other) on follow-up.
Time frame: 12 months
Oncological Outcomes: Post IRE Chemotherapy
Any use of chemotherapy after IRE
Time frame: 12 months
Oncological Outcomes: Other liver-directed interventions
Any further liver-directed, anti-cancer intervention including surgery and radiotherapy.
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Time frame: 12 months
Oncological Outcomes: Disease-free and overall survival from time of IRE.
Disease-free and overall survival from time of IRE.
Time frame: 12 months
Quality of life - pre procedure
EQ-5D-5L survey
Time frame: pre procedure up to 7 days
Quality of life - 7 days follow-up
EQ-5D-5L survey
Time frame: 7 days
Quality of life - 6 months
EQ-5D-5L survey
Time frame: 6 months