Journal Article

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

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

2018

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Ablation / Ablation (Surgery) / Analysis / Biomedicine / Blood vessels / Cancer metastasis / Care and treatment / Chemotherapy / Chemotherapy, Adjuvant / Colorectal cancer / Colorectal neoplasms / Colorectal Neoplasms - mortality / Colorectal Neoplasms - pathology / Comparative analysis / Cost analysis / Cost control / Cost-benefit analysis / Disease-Free Survival / Equivalence Trials as Topic / Excision (Surgery) / General anesthesia / Health aspects / Health Sciences / Hepatectomy / Hepatectomy - adverse effects / Hepatectomy - mortality / Humans / Liver / Liver Neoplasms - mortality / Liver Neoplasms - secondary / Liver Neoplasms - surgery / Local anesthesia / Medicine / Medicine & Public Health / Metastasis / Microwaves - adverse effects / Microwaves - therapeutic use / Morbidity / Mortality / Multicenter Studies as Topic / Necrosis / Neoplasm metastasis / Netherlands / Patient outcomes / Patients / Pilot Projects / Postoperative Complications - etiology / Pragmatic Clinical Trials as Topic / Prospective Studies / Quality of life / Radiofrequency Ablation - adverse effects / Radiofrequency Ablation - mortality / Randomised controlled trial / Recovery (Medical) / Statistics for Life Sciences / Study Protocol / Surgery / Systematic review / Time Factors / Treatment Outcome / Ultrasonic imaging / United Kingdom