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
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. This is based on a per-lesion analysis.
Time frame: 6 months
Complications of IRE: Episode-related complications:
Episode-related complications of IRE using the Clavien-Dindo system and the comprehensive complication index (CCI)
Time frame: 30 days
Complications of IRE: Intervention for local liver-related complications of IRE
Any intervention for local liver-related complications of IRE within 12 months of procedure. Interventions will be categorised as radiological, surgical or medical.
Time frame: 12 months
Oncological outcomes: Incomplete ablation requiring further intervention
Re-ablation and modality.
Time frame: 6 months
Oncological Outcome: Progression at site of ablation
Appearance of new lesions in liver, lungs, peritoneum or elsewhere (other) on follow-up.
Time frame: 12 months
Oncological outcome: Further anti-cancer intervention
Any further liver-directed, anti-cancer intervention including TACE and SIRT
Time frame: 12 months
Oncological Outcome: Survival (Progression-free & overall)
Progression-free and overall survival at 12 months from time of IRE.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oncologic Outcomes: local progression
Local progression at site of IRE-treated lesion.
Time frame: 12 months
Oncologic Outcomes: Chemotherapy post-IRE
Any use of chemotherapy after IRE.
Time frame: 6 months
Quality of life: EQ-5D-5 pre-procedure
Effect of intervention on quality of life as assessed by EQ-5D-5
Time frame: 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
Time frame: 7 days
Quality of life: EQ-5D-5 - 6 months
Effect of intervention on quality of life as assessed by EQ-5D-5
Time frame: 6 months