Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Baden-Württemberg, Germany.
Center for Surgery, Department of General and Visceral Surgery, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Baden-Württemberg, Germany.
BMJ Open. 2021 Jan 28;11(1):e044190. doi: 10.1136/bmjopen-2020-044190.
In current medical practice of curative treatment for non-metastatic oesophageal cancer, surgery on principle is carried out by oesophagectomy after neoadjuvant treatment. However, oesophagectomy is often associated with postoperative morbidity and mortality. Taking into account that modern neoadjuvant therapy is effective and many of patients show no vital tumour cells in the operative specimens, we aim to perform a scoping review as part of the development phase for a prospectively planned multicentre randomised controlled trial investigating 'surgery as needed vs surgery on principle in patients with postneoadjuvant complete response of oesophageal cancer' (Prospective trial registration number DRKS00022801). This scoping approach will allow us to finally define and/or adapt the research question including the design and methodology of the randomised controlled trial taking into account the findings for example, research gaps and/or pitfalls in the currently available study pool addressing this or very similar questions.
To identify relevant research, we will conduct searches in the electronic databases Medline, Web of Science Core Collection, Cochrane Library and Science Direct. We will also check references of relevant studies and perform a cited reference research (forward citation tracking). Titles and abstracts of the records identified by the searches will be screened and full texts of all potentially relevant articles will be obtained. We will consider randomised trials and non-randomised controlled studies. Data extraction tables will be set up, including study and patients' characteristics, aim of study and reported outcomes. We will summarise the data using tables and figures (eg, bubble plots) to present the research landscape and to describe potential clusters and/or gaps to support the planning of a randomised trial in this patient population.
Ethical approval is not required for this scoping review. Study findings will be shared by publication in a peer-reviewed journal and by presentation to key stakeholders on scientific meetings.
在当前非转移性食管癌的治疗实践中,原则上在新辅助治疗后进行食管切除术。然而,食管切除术常伴有术后发病率和死亡率。考虑到现代新辅助治疗是有效的,并且许多患者在手术标本中没有发现有活力的肿瘤细胞,我们旨在进行范围界定审查,作为前瞻性计划的多中心随机对照试验的开发阶段的一部分,该试验调查“新辅助治疗完全缓解后按需手术与原则上手术治疗食管癌患者”(前瞻性试验注册号 DRKS00022801)。这种方法将使我们能够最终定义和/或调整研究问题,包括随机对照试验的设计和方法学,考虑到研究结果,例如,目前针对该问题或非常相似问题的研究库中存在的研究差距和/或陷阱。
为了确定相关研究,我们将在电子数据库 Medline、Web of Science Core Collection、Cochrane Library 和 Science Direct 中进行搜索。我们还将检查相关研究的参考文献,并进行引用参考文献研究(向前引文跟踪)。将筛选搜索中确定的记录的标题和摘要,并获取所有潜在相关文章的全文。我们将考虑随机试验和非随机对照研究。将设置数据提取表,包括研究和患者特征、研究目的和报告的结果。我们将使用表格和图形(例如,气泡图)汇总数据,以呈现研究格局并描述潜在的聚类和/或差距,以支持在该患者人群中进行随机试验的规划。
本范围界定审查不需要伦理批准。研究结果将通过在同行评议期刊上发表和在科学会议上向主要利益相关者展示来共享。