Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
Gastroenterology. 2018 May;154(6):1682-1693.e1. doi: 10.1053/j.gastro.2018.01.063. Epub 2018 Feb 6.
BACKGROUND & AIMS: Real-time differentiation of diminutive polyps (1-5 mm) during endoscopy could replace histopathology analysis. According to guidelines, implementation of optical diagnosis into routine practice would require it to identify rectosigmoid neoplastic lesions with a negative predictive value (NPV) of more than 90%, using histologic findings as a reference, and agreement with histology-based surveillance intervals for more than 90% of cases.
We performed a prospective study with 39 endoscopists accredited to perform colonoscopies on participants with positive results from fecal immunochemical tests in the Bowel Cancer Screening Program at 13 centers in the Netherlands. Endoscopists were trained in optical diagnosis using a validated module (Workgroup serrAted polypS and Polyposis). After meeting predefined performance thresholds in the training program, the endoscopists started a 1-year program (continuation phase) in which they performed narrow band imaging analyses during colonoscopies of participants in the screening program and predicted histological findings with confidence levels. The endoscopists were randomly assigned to groups that received feedback or no feedback on the accuracy of their predictions. Primary outcome measures were endoscopists' abilities to identify rectosigmoid neoplastic lesions (using histology as a reference) with NPVs of 90% or more, and selecting surveillance intervals that agreed with those determined by histology for at least 90% of cases.
Of 39 endoscopists initially trained, 27 (69%) completed the training program. During the continuation phase, these 27 endoscopists performed 3144 colonoscopies in which 4504 diminutive polyps were removed. The endoscopists identified neoplastic lesions with a pooled NPV of 90.8% (95% confidence interval 88.6-92.6); their proposed surveillance intervals agreed with those determined by histologic analysis for 95.4% of cases (95% confidence interval 94.0-96.6). Findings did not differ between the group that did vs did not receive feedback. Sixteen endoscopists (59%) identified rectosigmoid neoplastic lesions with NPVs greater than 90% and selected surveillance intervals in agreement with those determined from histology for more than 90% of patients.
In a prospective study following a validated training module, we found that a selected group of endoscopists identified rectosigmoid neoplastic lesions with pooled NPVs greater than 90% and accurately selected surveillance intervals for more than 90% of patients over the course of 1 year. Providing regular interim feedback on the accuracy of neoplastic lesion prediction and surveillance interval selection did not lead to differences in those endpoints. Monitoring is suggested, as individual performance varied. ClinicalTrials.gov no: NCT02516748; Netherland Trial Register: NTR4635.
实时区分直径 1-5 毫米的微小息肉可替代组织病理学分析。根据指南，如果要将光学诊断应用于常规实践，那么其需要使用组织学发现作为参考，以超过 90%的阴性预测值（NPV）识别直肠乙状结肠肿瘤性病变，并与超过 90%的病例的基于组织学的监测间隔一致。
我们对来自荷兰 13 个中心的参加粪便免疫化学检测阳性的 Bowel Cancer Screening Program 的参与者进行了前瞻性研究，共有 39 名接受过结肠镜检查的内镜医师参与了该研究。内镜医师使用经过验证的模块（工作组区分息肉和息肉病）接受了光学诊断培训。在培训计划中达到预定义的性能阈值后，内镜医师开始进行为期 1 年的计划（延续阶段），在此期间，他们在筛查计划中参与者的结肠镜检查中进行窄带成像分析，并使用置信水平预测组织学发现。内镜医师被随机分配到接受或不接受预测准确性反馈的组中。主要观察指标是内镜医师识别直肠乙状结肠肿瘤性病变（以组织学为参考）的能力，其 NPV 超过 90%，以及选择与组织学确定的监测间隔一致的间隔，至少达到 90%的病例。
在最初接受培训的 39 名内镜医师中，有 27 名（69%）完成了培训计划。在延续阶段，这 27 名内镜医师进行了 3144 例结肠镜检查，切除了 4504 个微小息肉。内镜医师识别出的肿瘤性病变的总体 NPV 为 90.8%（95%置信区间 88.6-92.6）；他们提出的监测间隔与组织学分析确定的监测间隔一致，占 95.4%的病例（95%置信区间 94.0-96.6）。两组之间的发现没有差异。16 名（59%）内镜医师识别出的直肠乙状结肠肿瘤性病变的 NPV 大于 90%，并选择了与组织学确定的监测间隔一致的监测间隔，超过 90%的患者。
在一项前瞻性研究中，我们使用经过验证的培训模块发现，一组经过选择的内镜医师识别出的直肠乙状结肠肿瘤性病变的 NPV 大于 90%，并在 1 年内准确地为超过 90%的患者选择了监测间隔。定期提供关于肿瘤性病变预测和监测间隔选择准确性的反馈并不会导致这些终点出现差异。建议进行监测，因为个体表现存在差异。临床试验注册：NCT02516748；荷兰试验注册处：NTR4635。
