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

被引:39
作者
Gurusamy, Kurinchi [1 ]
Corrigan, Neil [2 ]
Croft, Julie [2 ]
Twiddy, Maureen [3 ]
Morris, Stephen [4 ]
Woodward, Nick [5 ]
Bandula, Steve [6 ]
Hochhauser, Daniel [7 ]
Napp, Vicky [2 ]
Pullan, Alison [2 ]
Jakowiw, Nicholas [1 ]
Prasad, Raj [8 ]
Damink, Steven Olde [9 ]
van Laarhoven, C. J. H. M. [10 ]
de Wilt, Johannes H. W. [10 ]
Brown, Julia [2 ]
Davidson, Brian R. [1 ]
机构
[1] UCL, Div Surg & Intervent Sci, Royal Free Hosp, Royal Free Campus,9th Floor,Rowland Hill St, London NW3 2PF, England
[2] Univ Leeds, Leeds Inst Clin Trials Res Unit, Clin Trials Res Unit, Leeds, W Yorkshire, England
[3] Univ Hull, Inst Clin & Appl Hlth Res, Kingston Upon Hull, N Humberside, England
[4] UCL, Dept Appl Hlth Res, London, England
[5] Royal Free Hosp, Dept Radiol, London, England
[6] Univ Coll London Hosp, Dept Radiol, London, England
[7] UCL, Canc Inst, London, England
[8] Leeds Teaching Hosp, Dept Surg & Transplantat, Leeds, W Yorkshire, England
[9] Maastricht Univ, Dept Gen Surg, Maastricht, Netherlands
[10] Radboud Univ Nijmegen Med Ctr, Dept Surg, Radboud, Netherlands
基金
美国国家卫生研究院;
关键词
Randomised controlled trial; Cost-benefit analysis; Liver; Neoplasm metastasis; Colorectal neoplasms; Hepatectomy; Ablation techniques; RADIOFREQUENCY ABLATION; MICROWAVE ABLATION; SURGICAL COMPLICATIONS; HEPATIC METASTASES; COST-EFFECTIVENESS; CANCER; MANAGEMENT; OUTCOMES; HEPATECTOMY; CLASSIFICATION;
D O I
10.1186/s13063-018-2499-5
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
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.
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页数:13
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