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. 2018 Feb 13;19(1):105.
doi: 10.1186/s13063-018-2499-5.

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

Kurinchi Gurusamy  1 , Neil Corrigan  2 , Julie Croft  2 , Maureen Twiddy  3 , Stephen Morris  4 , Nick Woodward  5 , Steve Bandula  6 , Daniel Hochhauser  7 , Vicky Napp  2 , Alison Pullan  2 , Nicholas Jakowiw  1 , Raj Prasad  8 , Steven Olde Damink  9 , C J H M van Laarhoven  10 , Johannes H W de Wilt  10 , Julia Brown  2 , Brian R Davidson  11
Affiliations

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

Kurinchi Gurusamy et al. Trials. .

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.

Keywords: Ablation techniques; Colorectal neoplasms; Cost-benefit analysis; Hepatectomy; Liver; Neoplasm metastasis; Randomised controlled trial.

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Conflict of interest statement

Ethics approval and consent to participate

Ethics approval was obtained from London - Hampstead Research Ethics Committee (REC reference no. 16/LO/0058). All participants will sign a consent form before participating in the trial.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Trial schema. The figure shows the pathway that participants who are potentially eligible for the trial follow
See this image and copyright information in PMC

References

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