Liver resection surgery versus thermal ablation for colorectal liver metastases

ISRCTN	ISRCTN52040363
DOI	https://doi.org/10.1186/ISRCTN52040363
Secondary identifying numbers	20592

Submission date: 09/03/2016
Registration date: 09/03/2016
Last edited: 11/05/2020

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-surgery-ablation-treatment-people-bowel-cancer-spread-liver-lava

Contact information

Ms Julie Croft
Public

University of Leeds
Clinical Trials Research Unit
17 Springfield Mount
Leeds
LS2 9JT
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	LAVA: Liver resection surgery versus thermal Ablation for colorectal liVer metAstases
Study acronym	LAVA
Study objectives	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(s)	16/LO/0058
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2016
Completion date	30/09/2020
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 330; UK Sample Size: 252
Total final enrolment	9
Key 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
Key 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
Date of first enrolment	01/10/2016
Date of final enrolment	30/09/2020

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Leeds

Clinical Trials Research Unit
17 Springfield Mount
Leeds
LS2 9JT
United Kingdom

Sponsor information

University College London
Hospital/treatment centre

R&D (1st Floor, Maple House)
Rossenheim Building
235 Euston Road
London
NW1 2BU
England
United Kingdom

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	31/08/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	13/02/2018		Yes	No
Results article	results	01/04/2020	11/05/2020	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

11/05/2020: Publication reference and total final enrolment number added.
23/11/2018: The trial was stopped on 31/08/2018 due to recruitment issues. The intention to publish date was changed from 30/09/2021 to 31/08/2019.
15/02/2018: Publication reference added.
20/03/2017: Cancer Help UK lay summary link added to plain English summary field.