Accuracy of endoscopic staging and targeted biopsies for routine gastric intestinal metaplasia and gastric atrophy evaluation study protocol of a prospective, cohort study: the estimate study.
Accuracy of endoscopic staging and targeted biopsies for routine gastric intestinal metaplasia and gastric atrophy evaluation study protocol of a prospective, cohort study: the estimate study.
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一项前瞻性队列研究的常规胃肠化生和胃萎缩评估研究方案的内镜分期和靶向活检的准确性：估计研究。
DOI：
10.1136/bmjopen-2019-032013
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发表时间：
2019
期刊：
影响因子：
2.9
通讯作者：
Nieuwenburg SAV
中科院分区：
文献类型：
--
作者：
Nieuwenburg SAV
慢性萎缩性胃炎(CAG)和肠化生(IM)患者有发生胃腺癌的危险。他们的诊断和治疗目前依赖于随机内窥镜活检抽样后的组织病理学指导(悉尼活检战略)。该方法存在漏诊率低、重复性差、内窥镜检查与组织学相关性差等缺点。这项前瞻性的国际多中心研究旨在确定内窥镜引导的风险分层是否能准确和可重复性地预测CAG和IM的程度和疾病分期。方法和分析标准白光内窥镜(WLE)的CAG和/或IM患者将被前瞻性地识别并邀请专家内窥镜专家使用增强的内窥镜成像技术和虚拟彩色内窥镜进行第二次内窥镜检查。CAG/IM的范围将通过增强成像在内窥镜下进行分期，并与标准的WLE进行比较。通过有针对性的活检进行的组织病理学风险分层将与内窥镜疾病分期和WLE的随机活检分期进行比较，作为参考。至少234名患者被要求在增强成像内窥镜引导的分期和当前活检引导的胃萎缩分期方案之间显示出10 %的敏感性和准确性差异，功率(BETA)为80 %，I型错误的概率(α)为0.05。这些发现将发表在同行评议的期刊上，并在科学会议上公布。试验注册号NTR7661；预结果。
IntroductionPatients with chronic atrophic gastritis (CAG) and intestinal metaplasia (IM) are at risk of developing gastric adenocarcinoma. Their diagnosis and management currently rely on histopathological guidance after random endoscopic biopsy sampling (Sydney biopsy strategy). This approach has significant flaws such as under-diagnosis, poor reproducibility and poor correlation between endoscopy and histology. This prospective, international multicentre study aims to establish whether endoscopy-led risk stratification accurately and reproducibly predicts CAG and IM extent and disease stage.Methods and analysisPatients with CAG and/or IM on standard white light endoscopy (WLE) will be prospectively identified and invited to undergo a second endoscopy performed by an expert endoscopist using enhanced endoscopic imaging techniques with virtual chromoendoscopy. Extent of CAG/IM will be endoscopically staged with enhanced imaging and compared with standard WLE. Histopathological risk stratification through targeted biopsies will be compared with endoscopic disease staging and to random biopsy staging on WLE as a reference. At least 234 patients are required to show a 10 % difference in sensitivity and accuracy between enhanced imaging endoscopy-led staging and the current biopsy-led staging protocol of gastric atrophy with a power (beta) of 80 % and a 0.05 probability of a type I error (alpha).Ethics and disseminationThe study was approved by the respective Institutional Review Boards (Netherlands: MEC-2018-078; UK: 19/LO/0089). The findings will be published in peer-reviewed journals and presented at scientific meetings.Trial registration numberNTR7661; Pre-results.