Colorectal Adenocarcinoma Metastatic in the Liver, Liver Ablation, Liver Cancer, Adult
Conditions
Keywords
irreversible electroporation, liver ablation, metastatic liver disease, nanoknife, liver ire registry
Brief summary
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.
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 liver metastases from colorectal cancer in patients who have received systemic chemotherapy.
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 histological confirmation of a diagnosis of colorectal cancer from primary tumour. * Liver lesions demonstrating radiological characteristics (on magnetic resonance scan) of colorectal hepatic metastases without requirement for biopsy. In the setting of an intact liver, patients with up to four metastases ≤ 4cm in size are eligible for inclusion. In the setting of proposed resection plus ablation, up to two metastases ≤ 4cm in size. In the setting of recurrence after prior hepatectomy up to two metastases ≤ 4cm in size. * Eastern Co-operative Oncology Group (ECOG) Score ≤ 2. * Rockwood Frailty Score ≤ 3. * Serum bilirubin \< 30 µmol/L. * Serum creatinine \< 150 µmol/L. * Up to two lung metastases (\< 2cm in size permitted at enrolment). * Prior treatment with at least one course of systemic chemotherapy (± biologic agent) mandated. Chemotherapy protocol is not specified and is at clinician discretion. * Primary rectal tumour can remain in situ treated with radiotherapy/chemoradiotherapy according to tumour board recommendations. Primary colonic tumour can remain in situ. * No prior hepatic tumour ablation
Exclusion criteria
* Patients involved in other research studies. * Inability to give informed consent. * Patients who are pregnant. * 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 ≥ 4 cm in size. * Advanced multi-site metastatic cancer (any of the following): peritoneal metastases (M1c), bone metastases, \> 2 lung metastases, all segment involvement multiple liver metastases. * Jaundice (serum bilirubin \> 30 µmol/L). * MDT/tumour recommends use of thermal ablation instead of IRE 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications of IRE: Intervention for local liver-related complications of IRE | 12 months | Intervention for local liver-related complications of IRE within 12 months of the procedure categorised as radiological, surgical or medical |
| Oncological outcomes: Local progression at site of IRE-treated lesion | 12 months | Local progression at site of IRE-treated lesion |
| Oncological Outcomes: Re-ablation and modality. | 12 months | Re-ablation and modality. |
| Oncological Outcomes: New lesions | 12 months | Appearance of new lesions in liver, lungs, peritoneum or elsewhere (other) on follow-up. |
| Oncological Outcomes: Post IRE Chemotherapy | 12 months | Any use of chemotherapy after IRE |
| Complications of IRE: Episode-related complications: | 30 days | All complications recorded during inpatient stay recorded using Clavien-Dindo and CCI |
| Oncological Outcomes: Disease-free and overall survival from time of IRE. | 12 months | Disease-free and overall survival from time of IRE. |
| Quality of life - pre procedure | pre procedure up to 7 days | EQ-5D-5L survey |
| Quality of life - 7 days follow-up | 7 days | EQ-5D-5L survey |
| Quality of life - 6 months | 6 months | EQ-5D-5L survey |
| Oncological Outcomes: Other liver-directed interventions | 12 months | Any further liver-directed, anti-cancer intervention including surgery and radiotherapy. |
Countries
United Kingdom
Contacts
Primary ContactMitchell Vanderpoll
Outcome results
None listed