Wong Lye-Yeng, Li Yanli, Elliott Irmina A, Backhus Leah M, Berry Mark F, Shrager Joseph B, Oh Daniel S
Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, Calif.
Department of Medical Affairs, Intuitive Surgical, Sunnyvale, Calif.
JTCVS Open. 2024 Jan 20;18:234-252. doi: 10.1016/j.xjon.2024.01.008. eCollection 2024 Apr.
Randomized control trials are considered the highest level of evidence, yet the scalability and practicality of implementing randomized control trials in the thoracic surgical oncology space are not well described. The aim of this study is to understand what types of randomized control trials have been conducted in thoracic surgical oncology and ascertain their success rate in completing them as originally planned.
The ClinicalTrials.gov database was queried in April 2023 to identify registered randomized control trials performed in patients with lung cancer who underwent surgery (by any technique) as part of their treatment.
There were 68 eligible randomized control trials; 33 (48.5%) were intended to examine different perioperative patient management strategies (eg, analgesia, ventilation, drainage) or to examine different intraoperative technical aspects (eg, stapling, number of ports, port placement, ligation). The number of randomized control trials was relatively stable over time until a large increase in randomized control trials starting in 2016. Forty-four of the randomized control trials (64.7%) were open-label studies, 43 (63.2%) were conducted in a single facility, 66 (97.1%) had 2 arms, and the mean number of patients enrolled per randomized control trial was 236 (SD, 187). Of 21 completed randomized control trials (31%), the average time to complete accrual was 1605 days (4.4 years) and average time to complete primary/secondary outcomes and adverse events collection was 2125 days (5.82 years).
Given the immense investment of resources that randomized control trials require, these findings suggest the need to scrutinize future randomized control trial proposals to assess the likelihood of successful completion. Future study is needed to understand the various contributing factors to randomized control trial success or failure.
随机对照试验被认为是证据的最高级别，但在胸外科肿瘤领域开展随机对照试验的可扩展性和实用性尚未得到充分描述。本研究的目的是了解在胸外科肿瘤领域进行了哪些类型的随机对照试验，并确定其按原计划完成的成功率。
于2023年4月查询ClinicalTrials.gov数据库，以识别在接受手术（采用任何技术）作为治疗一部分的肺癌患者中进行的已注册随机对照试验。
有68项符合条件的随机对照试验；33项（48.5%）旨在研究不同的围手术期患者管理策略（如镇痛、通气、引流）或研究不同的术中技术方面（如吻合器使用、端口数量、端口放置、结扎）。随机对照试验的数量随时间相对稳定，直到2016年开始大幅增加。44项随机对照试验（64.7%）为开放标签研究，43项（63.2%）在单一机构进行，66项（97.1%）有两个组，每项随机对照试验的平均入组患者数为236名（标准差为187）。在21项已完成的随机对照试验（31%）中，完成入组的平均时间为1605天（4.4年），完成主要/次要结局及不良事件收集的平均时间为2125天（5.82年）。
鉴于随机对照试验需要巨大的资源投入，这些发现表明有必要仔细审查未来的随机对照试验提案，以评估成功完成的可能性。需要进一步研究以了解随机对照试验成败的各种影响因素。
