Bennett Cathy, Green Susi, Decaestecker John, Almond Max, Barr Hugh, Bhandari Pradeep, Ragunath Krish, Singh Rajvinder, Jankowski Janusz
Centre for Digestive Diseases, Blizard Institute, Queen Mary, University of London, London, UK.
Cochrane Database Syst Rev. 2012 Nov 14;11:CD007334. doi: 10.1002/14651858.CD007334.pub4.
Barrett's oesophagus is one of the most common pre-malignant lesions in the world. Currently the mainstay of therapy is surgical management of advanced cancer but this has improved the five-year survival very little since the 1980s. As a consequence, improved survival relies on early detection through endoscopic surveillance programmes. Success of this strategy relies on the fact that late-stage pre-malignant lesions or very early cancers can be cured by intervention. Currently there is considerable controversy over which method is best: that is conventional open surgery or endotherapy (techniques involving endoscopy).
We used data from randomised controlled trials (RCTs) to examine the effectiveness of endotherapies compared with surgery in people with Barrett's oesophagus, those with early neoplasias (defined as high-grade dysplasia (HGD) and those with early cancer (defined as carcinoma in-situ, superficially invasive, early cancer or superficial cancer T-1m (T1-a) and T-1sm (T1-b)).
We used the Cochrane highly sensitive search strategy to identify RCTs in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, EBMR, Controlled Trials mRCT and ISRCTN, and LILACS, in July and August 2008. The searches were updated in 2009 and again in April 2012.
Types of studies: RCTs comparing endotherapies with surgery in the treatment of or early cancer. All cellular types of cancer were included (i.e. adenocarcinomas, squamous cell carcinomas and more unusual types) but will be discussed separately.
patients of any age and either gender with a histologically confirmed diagnosis of early neoplasia (HGD and early cancer) in Barrett's or squamous lined oesophagus.Types of interventions; endotherapies (the intervention) compared with surgery (the control), all with curative intent.
Reports of studies that meet the inclusion criteria for this review would have been analysed using the methods detailed in Appendix 9.
We did not identify any studies that met the inclusion criteria. In total we excluded 13 studies that were not RCTs but that compared surgery and endotherapies.
AUTHORS' CONCLUSIONS: This Cochrane review has indicated that there are no RCTs to compare management options in this vital area, therefore trials should be undertaken as a matter of urgency. The problems with such randomised methods are standardising surgery and endotherapies in all sites, standardising histopathology in all centres, assessing which patients are fit or unfit for surgery and making sure there are relevant outcomes for the study (i.e. long-term survival (over five or more years)) and no progression of HGD.
巴雷特食管是全球最常见的癌前病变之一。目前，晚期癌症的主要治疗方法是手术，但自20世纪80年代以来，这一方法对五年生存率的改善甚微。因此，提高生存率依赖于通过内镜监测计划进行早期检测。该策略的成功依赖于晚期癌前病变或极早期癌症可通过干预治愈这一事实。目前，关于哪种方法最佳存在相当大的争议：即传统开放手术还是内镜治疗（涉及内镜的技术）。
我们使用随机对照试验（RCT）的数据，比较内镜治疗与手术治疗在巴雷特食管患者、早期肿瘤形成患者（定义为高级别异型增生（HGD））以及早期癌症患者（定义为原位癌、浅表浸润性癌、早期癌或浅表癌T-1m（T1-a）和T-1sm（T1-b））中的有效性。
我们于2008年7月和8月使用Cochrane高度敏感检索策略，在MEDLINE、EMBASE、Cochrane对照试验中央注册库（CENTRAL）、ISI科学网、EBMR、对照试验mRCT和ISRCTN以及LILACS中识别RCT。检索在2009年更新，并于2012年4月再次更新。
研究类型：比较内镜治疗与手术治疗早期癌症的RCT。纳入所有细胞类型的癌症（即腺癌、鳞状细胞癌和更罕见的类型），但将分别进行讨论。
任何年龄和性别的患者，经组织学确诊为巴雷特食管或鳞状上皮食管的早期肿瘤形成（HGD和早期癌症）。干预类型：内镜治疗（干预措施）与手术（对照）比较，均具有治愈意图。
符合本综述纳入标准的研究报告将使用附录9中详述的方法进行分析。
我们未识别出任何符合纳入标准的研究。总共排除了13项非RCT但比较手术和内镜治疗的研究。
本Cochrane综述表明，在这一关键领域尚无RCT来比较治疗方案，因此应作为紧急事项开展试验。此类随机方法存在的问题包括在所有部位规范手术和内镜治疗、在所有中心规范组织病理学、评估哪些患者适合或不适合手术以及确保研究有相关结局（即长期生存（超过五年或更长时间））且HGD无进展。
