Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial

Gurusamy, Kurinchi; Corrigan, Neil; Croft, Julie; Twiddy, Maureen; Morris, Stephen; Woodward, Nick; Bandula, Steve; Hochhauser, Daniel; Napp, Vicky; Pullan, Alison; Jakowiw, Nicholas; Prasad, Raj; Damink, Steven Olde; van Laarhoven, C. J.H.M.; de Wilt, Johannes H.W.; Brown, Julia; Davidson, Brian R.

Abstract

Background:Although surgical resection has been considered the only curative option for colorectal livermetastases (CLM), thermal ablation has recently been suggested as an alternative curative treatment. A prospective randomised trial is required to define the efficacy of resection vs ablation for the treatment of colorectal liver metastases.Methods:Design and setting:This is a multicentre, open, randomised controlled non-inferiority trial design with internal pilot and will be performed in tertiary liver centres in UK and The Netherlands.
Participants:Eligible patients will be those with colorectal liver metastases at high surgical risk because of their age,co-morbidities or tumour burden and who would be suitable for liver resection or thermal ablation.
Intervention:Thermal ablation as per local policy.Control:Surgical liver resection performed as per centre protocol.
Co-interventions: Further chemotherapy will be offered to patients as per current practice.
Outcomes Pilot study: Same as main study and in addition patients and clinicians’acceptability of the trial to assist in optimisation of recruitment.
Primary outcome: Disease-free survival (DFS) at two years post randomisation.
Secondary outcomes: Overall survival, timing and site of recurrence, additional therapy after treatment failure,quality of life, complications, length of hospital stay, costs, trial acceptability, DFS measured from end of intervention.Follow-up:24 months from randomisation; five-year follow-up for overall survival.Sample size:330 patients to demonstrate non-inferiority of thermal ablation.Discussion:This trial will determine the effectiveness and cost-effectiveness of thermal ablation vs surgical resection for high-risk people with colorectal liver metastases, and guide the optimal treatment for these patients.Trial registration: ISRCTN Registry, ISRCTN52040363. Registered on 9 March 2016

Citation

Gurusamy, K., Corrigan, N., Croft, J., Twiddy, M., Morris, S., Woodward, N., Bandula, S., Hochhauser, D., Napp, V., Pullan, A., Jakowiw, N., Prasad, R., Damink, S. O., van Laarhoven, C. J., de Wilt, J. H., Brown, J., & Davidson, B. R. (2018). Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial. Trials, 19(1), https://doi.org/10.1186/s13063-018-2499-5

• Journal Article Type: Article
• Acceptance Date: Jan 24, 2018
• Online Publication Date: Feb 13, 2018
• Publication Date: Feb 13, 2018
• Deposit Date: Apr 30, 2018
• Publicly Available Date: Apr 30, 2018
• Journal: Trials
• Print ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 19
• Issue: 1
• DOI: https://doi.org/10.1186/s13063-018-2499-5
• Keywords: Medicine (miscellaneous); Pharmacology (medical)
• Public URL: https://hull-repository.worktribe.com/output/613244
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2499-5
• Contract Date: Apr 30, 2018