Graduate School, Beijing University of Chinese Medicine, Beijing, China.
Oncology Department, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.
BMJ Open. 2020 Sep 6;10(9):e033460. doi: 10.1136/bmjopen-2019-033460.
National Comprehensive Cancer Network has recommended cryoablation to replace the resection in the treatment of medically operable non-small cell lung cancer (NSCLC). Cryoablation also has been used for the advanced NSCLC in randomised controlled trials. However, they have not been systematically reviewed. Here, we provide a protocol to evaluate the effectiveness and safety of cryoablation in the treatment of advanced NSCLC.
We will search PubMed, Embase, the Cochrane Library, Chinese Biomedical Database, China National Knowledge Infrastructure, Wanfang Database and Chinese Scientific Journal Database without language restrictions from inception until 1 February 2020. Trial registers (International Clinical Trials Registry platform, the US National Institutes of Health Ongoing Trials Register and the ISRCTN registry) and reference lists of retrieved articles will also be searched. Two reviewers will independently extract data on participants, interventions, comparisons, outcomes and assess the methodological quality by the Cochrane risk of bias tool. The strength of evidences will be evaluated according to the Grading of Recommendations Assessment, Development and Evaluation approach. Review Manager V.5.3 software will be used for data analyses. Meta-analyses will be performed if the data are sufficiently homogeneous. The primary outcomes will be objective response rate and overall survival. The secondary outcomes will be adverse effects, health-related quality of life, changes of immune indicators and surrogate outcomes (disease control rate, progression-free survival and survival rate).
Ethics approval is not required, as this study will not involve patients. The results of this study will be submitted to a peer-reviewed journal for publication, to inform both clinical practice and further research.
CRD42019138660.
美国国家综合癌症网络建议用冷冻消融术替代切除术来治疗适合手术的非小细胞肺癌（NSCLC）。冷冻消融术也已被用于随机对照试验中的晚期 NSCLC。然而，目前尚未对这些研究进行系统评价。本文旨在制定方案，以评估冷冻消融术治疗晚期 NSCLC 的有效性和安全性。
我们将对 PubMed、Embase、Cochrane 图书馆、中国生物医学文献数据库、中国知网、万方数据库和中国科技期刊数据库进行检索，检索时间为建库至 2020 年 2 月 1 日，无语言限制。同时还将检索试验注册库（国际临床试验注册平台、美国国立卫生研究院正在进行的试验注册库和 ISRCTN 注册库）和纳入文献的参考文献列表。两名评审员将独立提取参与者、干预措施、比较、结局等数据，并采用 Cochrane 偏倚风险工具评估方法学质量。将根据推荐评估、制定与评价分级方法评估证据强度。Review Manager V.5.3 软件将用于数据分析。如果数据足够同质，将进行荟萃分析。主要结局指标为客观缓解率和总生存期。次要结局指标为不良反应、健康相关生活质量、免疫指标变化和替代结局（疾病控制率、无进展生存期和生存率）。
本研究无需伦理批准，因为它不涉及患者。研究结果将提交给同行评议期刊发表，为临床实践和进一步研究提供信息。
PROSPERO 注册号：CRD42019138660。
