Trials (Feb 2018)

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

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

DOI
https://doi.org/10.1186/s13063-018-2499-5
Journal volume & issue
Vol. 19, no. 1
pp. 1 – 13

Abstract

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Abstract Background Although surgical resection has been considered the only curative option for colorectal liver metastases (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.

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