CSF rhinorrhoea after endonasal intervention to the anterior skull base (CRANIAL): proposal for a prospective multicentre observational cohort study

The endonasal transsphenoidal approach (TSA) has emerged as the preferred approach in order to treat pituitary adenoma and related sellar pathologies. The recently adopted expanded endonasal approach (EEA) has improved access to the ventral skull base whilst retaining the principles of minimally invasive surgery. Despite the advantages these approaches offer, cerebrospinal fluid (CSF) rhinorrhoea remains a common complication. There is currently a lack of comparative evidence to guide the best choice of skull base reconstruction, resulting in considerable heterogeneity of current practice. This study aims to determine: (1) the scope of the methods of skull base repair; and (2) the corresponding rates of postoperative CSF rhinorrhoea in contemporary neurosurgical practice in the UK and Ireland. We will adopt a multicentre, prospective, observational cohort design. All neurosurgical units in the UK and Ireland performing the relevant surgeries (TSA and EEA) will be eligible to participate. Eligible cases will be prospectively recruited over 6 months with 6 months of postoperative follow-up. Data points collected will include: demographics, tumour characteristics, operative data), and postoperative outcomes. Primary outcomes include skull base repair technique and CSF rhinorrhoea (biochemically confirmed and/or requiring intervention) rates. Pooled data will be analysed using descriptive statistics. All skull base repair methods used and CSF leak rates for TSA and EEA will be compared against rates listed in the literature. Formal institutional ethical board review was not required owing to the nature of the study – this was confirmed with the Health Research Authority, UK. The need for this multicentre, prospective, observational study is highlighted by the relative paucity of literature and the resultant lack of consensus on the topic. It is hoped that the results will give insight into contemporary practice in the UK and Ireland and will inform future studies.

经鼻蝶窦入路（endonasal transsphenoidal approach, TSA）现已成为治疗垂体腺瘤及相关鞍区病变的首选手术入路。近年来推广的扩大经鼻入路（expanded endonasal approach, EEA）在保留微创手术原则的基础上，拓展了颅底腹侧的手术暴露范围。尽管此类入路具备诸多优势，但脑脊液鼻漏（cerebrospinal fluid rhinorrhoea, CSF）仍是其常见术后并发症。目前尚缺乏对比性证据以指导颅底重建的最优方案选择，导致当前临床实践存在显著异质性。
本研究旨在明确两大目标：（1）当前颅底修复术式的应用范畴；（2）英国与爱尔兰当代神经外科临床中，采用上述术式后对应的脑脊液鼻漏术后发生率。本研究将采用多中心前瞻性观察队列研究设计，英国与爱尔兰所有开展相关手术（TSA与EEA）的神经外科中心均可参与。合格病例将在6个月内完成前瞻性招募，并接受为期6个月的术后随访。收集的资料维度包括：人口统计学特征、肿瘤相关特征、手术相关数据及术后结局。主要结局指标包括颅底修复术式，以及经生化证实和/或需临床干预的脑脊液鼻漏发生率。汇总数据将采用描述性统计学方法进行分析，并将TSA与EEA所采用的各类颅底修复术式及脑脊液漏发生率与现有文献报道数据进行对比。本研究属于观察性研究，无需接受正式的机构伦理委员会审查，该结论已获英国健康研究管理局（Health Research Authority, UK）确认。鉴于当前相关文献较为匮乏，且该领域尚未形成共识，本项多中心前瞻性观察研究的必要性尤为凸显。本研究期望通过结果明确英国与爱尔兰的当代临床实践现状，为后续相关研究提供参考依据。