Topic: Surgery
Conditions
Interventions
Participants are randomly allocated to one of two treatment groups.
Surgical resection: Surgical liver resection will be performed in accordance with each site’s usual practice. Patie
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years 2. Able to provide written informed consent 3. MDT diagnosis of colorectal liver metastases considered to be resectable with curative intent 4. Resected colorectal primary or plan for primary resection with curative intent 5. Meets one or more of the following criteria: 5.1. Considered high risk for surgery due to age e.g. Age greater than 75 years of age 5.2. Major co-morbidities as judged by the treating clinician. Examples include history of myocardial infarction, severe chronic airway disease, major cerebrovascular accidents (CVA), pulmonary embolism (PE) 5.3. Liver metastases with poor prognosis and or high risk surgery due to tumour burden, Examples include extensive synchronous disease, need for two stage resection or ALLPS, small anticipated remnant liver volume, resectable or ablatable extra-hepatic disease, downstaged with chemotherapy, poor response after chemotherapy or portal vein embolization but still resectable 6. Suitable candidate for either liver resection surgery or thermal ablation as judged by the MDT 7. Able and willing to comply with the terms of the protocol including QoL questionnaire
Exclusion criteria
Exclusion criteria: 1. Incurable extra-hepatic metastases 2. Concurrent malignant disease (except basal cell carcinoma) 3. Patients who have undergone previous surgery or ablation for colorectal liver metastases 4. Planned simultaneous resection for primary and liver metastases disease 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival at 2 years is calculated from participant assessments at 3, 6, 12, 18 and 24 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Local and distant recurrence of disease at 2 years is calculated from participant assessments at 3, 6, 12, 18 and 24 months post-randomisation 2. Overall survival is determined at 2 and 5 years post-randomisation 3. Post treatment complications are recorded at participant assessments at 3, 6, 12, 18 and 24 months post-randomisation 4. Disease free survival (DFS) (measured from end of intervention) at 2 years post-randomisation 5. Use of subsequent therapies for treatment failure over 2 years post-randomisation 6. Health related quality of life is measured using EQ-5D, EORTC QLQ-C30, EORTC LMC21 at baseline 3 and 6 months post randomisation 7. Length of intensive therapy unit (ITU) and inpatient stay 8. Resource use collected retrospectively at 3, 6, 12, 18, and 24 months post-randomisation | — |
Countries
United Kingdom
Contacts
Public ContactJulie Croft
Outcome results
None listed