Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
20592
Study information
Scientific title
LAVA: Liver resection surgery versus thermal Ablation for colorectal liVer metAstases
Acronym
LAVA
Study hypothesis
The aim of this study is to compare the effectiveness of liver resection surgery and thermal ablation for the treatment of colorectal liver metastases.
Ethics approval
16/LO/0058
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Surgery; Subtopic: Surgery; Disease: Surgery (All Surgery)
Intervention
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. Patients may be offered open or laparoscopic liver resection depending on site and stage of disease. Procedures for patients with extensive metastatic disease can include two stage liver resection, venous embolization, or the ALPPS procedure (Associated Liver Partition and Portal vein ligation for Staged hepatectomy).
Thermal ablation: Either radiofrequency ablation (RFA) or microwave ablation (MWA) will be carried out according to the local availability of equipment and expertise. Ablation may be performed at laparoscopic or open surgery if the percutaneous approach is contra-indicated.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Disease free survival at 2 years is calculated from participant assessments at 3, 6, 12, 18 and 24 months post-randomisation
Secondary outcome measures
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
Overall trial start date
01/10/2016
Overall trial end date
30/09/2020
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 330; UK Sample Size: 252
Participant 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
Recruitment start date
01/10/2016
Recruitment end date
30/09/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Clinical Trials Research Unit
17 Springfield Mount
Leeds
LS2 9JT
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
31/08/2019
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29439711