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., …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
• Electronic 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