肝切除手术与热消融治疗结直肠癌肝转移（LAVA）：一项随机对照试验的研究方案
Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial.
作者信息
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
机构信息
Royal Free Campus, Division of Surgery and Interventional Science, University College London, 9th Floor, Royal Free Hospital, Rowland Hill Street, NW3 2PF, London, UK.
Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research Unit, University of Leeds, Leeds, UK.
出版信息
Trials. 2018 Feb 13;19(1):105. doi: 10.1186/s13063-018-2499-5.
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.
背景
尽管手术切除一直被认为是结直肠癌肝转移（CLM）的唯一治愈性选择，但最近有人提出热消融可作为一种替代性的治愈性治疗方法。需要进行一项前瞻性随机试验来确定手术切除与消融治疗结直肠癌肝转移的疗效。
方法
设计与设置：这是一项多中心、开放、随机对照的非劣效性试验设计，带有内部预试验，将在英国和荷兰的三级肝脏中心进行。
参与者
符合条件的患者将是那些因年龄、合并症或肿瘤负荷而具有高手术风险的结直肠癌肝转移患者，且适合进行肝切除或热消融。
干预
根据当地政策进行热消融。
对照
按照中心方案进行肝切除手术。联合干预：将根据当前实践为患者提供进一步的化疗。结果预试验：与主要研究相同，此外还包括患者和临床医生对试验的可接受性，以协助优化招募。
主要结局
随机分组后两年的无病生存期（DFS）。
次要结局
总生存期、复发时间和部位、治疗失败后的额外治疗、生活质量、并发症、住院时间、费用及试验的可接受性、从干预结束时开始测量的DFS。
随访
随机分组后24个月；对总生存期进行五年随访。
样本量
330例患者，以证明热消融的非劣效性。
讨论
本试验将确定热消融与手术切除对高危结直肠癌肝转移患者的有效性和成本效益，并指导这些患者的最佳治疗。
试验注册
国际标准随机对照试验编号（ISRCTN）注册库，ISRCTN52040363。于2016年3月9日注册。
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