Stallard Joseph, Loberg Anna, Dunning Joel, Dark John
Department of Cardiothoracic Surgery, James Cook University Hospital, Middlesbrough, UK.
Interact Cardiovasc Thorac Surg. 2010 Nov;11(5):660-6. doi: 10.1510/icvts.2010.245506. Epub 2010 Aug 19.
A best evidence topic was written according to a structured protocol. The question addressed was 'whether a sleeve lobectomy results in a better survival rate than a pneumonectomy in suitable patients?' Altogether, more than 327 papers were found using the reported search, of which 15 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. We conclude in the biggest meta-analysis of nearly 3000 patients, the five-year survival was 50% for sleeve lobectomy compared to 30% for pneumonectomy. Operative mortality was 3% vs. 6% for pneumonectomy, and locoregional recurrence was 17% vs. 30%. These results are broadly consistent across all the 13 cohort studies presented here many of which document a 20-year single centre experience or more. There are significant issues in all cohort studies on this subject as, due to their non-randomized nature, the reason for not performing a sleeve resection may well have been more advanced disease, which would necessarily mean that the pneumonectomy patients would have a lower expected survival and higher local recurrence. In addition, there have been many large cohort studies to date and thus no more are required, as future studies are unlikely to resolve this issue. Thus, the only study that would adequately correct for this issue would be a randomized trial, but to prove a 10% increase in five-year survival a 300 patient study would be needed. This is bigger than any study ever done in this area and as some centres took 30 years to collect these numbers of potential sleeve patients an RCT is not a realistic possibility. Therefore, we conclude that no more cohort studies should be performed, as the results will be consistent with the meta-analyses and an RCT to eliminate their bias is unattainable, and thus no more research should be done on this topic and surgeons should use the figures presented above and in more detail in this best evidence topic to govern their management in the future.
根据结构化方案撰写了一篇最佳证据主题。所探讨的问题是“在合适的患者中,袖状肺叶切除术的生存率是否高于全肺切除术?”通过报告的检索共找到327多篇论文,其中15篇代表了回答该临床问题的最佳证据。将这些论文的作者、期刊、发表日期和国家、研究的患者组、研究类型、相关结局和结果制成表格。我们在对近3000例患者进行的最大规模荟萃分析中得出结论,袖状肺叶切除术的五年生存率为50%,而全肺切除术为30%。全肺切除术的手术死亡率为6%,而袖状肺叶切除术为3%;局部区域复发率分别为30%和17%。这里呈现的所有13项队列研究结果大致一致,其中许多记录了长达20年的单中心经验或更长时间。关于这个主题的所有队列研究都存在重大问题,因为由于其非随机性质,未进行袖状切除术的原因很可能是疾病更晚期,这必然意味着全肺切除术患者的预期生存率更低且局部复发率更高。此外,迄今为止已经有许多大型队列研究,因此不再需要更多研究,因为未来的研究不太可能解决这个问题。因此,唯一能充分纠正这个问题的研究将是一项随机试验,但要证明五年生存率提高10%,则需要一项纳入300例患者的研究。这比该领域以往任何研究的规模都要大,而且由于一些中心花了30年才收集到这些潜在袖状切除术患者的数据,进行随机对照试验不太现实。因此,我们得出结论,不应再进行更多队列研究,因为结果将与荟萃分析一致,而且消除其偏倚的随机对照试验无法实现,因此不应再对此主题进行更多研究,外科医生应使用上述数据以及本最佳证据主题中更详细的数据来指导他们未来的治疗决策。