Semenov Serhiy, Costigan Conor, Ismail Mohd Syafiq, McNamara Deirdre
Trinity Academic Gastroenterology Group, Trinity Centre, Tallaght Hospital, Trinity College Dublin, D02 R590 Dublin, Ireland.
Department of Gastroenterology, Tallaght University Hospital, D24 NR0A Dublin, Ireland.
Diagnostics (Basel). 2022 Dec 25;13(1):56. doi: 10.3390/diagnostics13010056.
CCE is a diagnostic tool lacking clinical data on false negative rates. We aimed to assess this rate and the reader/technical error breakdown.
False negative CCEs were identified after comparing to a colonoscopy database. Missed pathology characteristics and study indications/quality were collated. Cases were re-read by experts and newly identified lesions/pathologies were verified by an expert panel and categorised as reader/technical errors.
Of 532 CCEs, 203 had an adequately reported comparative colonoscopy, 45 (22.2%) had missed polyps, and 26/45 (57.8%) reached the colonic section with missed pathology. Of the cases, 22 (84.6%) had adequate bowel preparation. Indications included 13 (50%) polyp surveillance, 12 (46%) GI symptoms, 1 (4%) polyp screening. CCE missed 18 (69.2%) diminutive polyps and 8 (30.8%) polyps ≥ 6 mm, 18/26 (69.2%) of these were adenomas. Excluding incomplete CCE correlates, colonoscopy total and significant polyp yield were 97/184 (52.7%) and 50/97 (51.5%), respectively. CCE total polyp and significant polyp false negative rate was 26.8% (26/97) and 16% (8/50), respectively. Following re-reading, reader and technical error was 20/26 (76.9%) and 6/26 (23.1%). Total and significant missed polyp rates were 20.6% (20/97) and 14% (7/50) for reader error, 6.2% (6/97) and 2% (1/50) for technical error.
False negative CCE rate is not insubstantial and should be factored into clinical decision making.
结肠胶囊内镜(CCE)作为一种诊断工具,缺乏关于假阴性率的临床数据。我们旨在评估该比率以及阅片者/技术失误的分类情况。
通过与结肠镜检查数据库进行比较来识别CCE假阴性病例。整理漏诊的病理特征以及研究适应证/质量情况。由专家重新阅片,新发现的病变/病理情况由专家小组进行核实,并分类为阅片者/技术失误。
在532例CCE检查中,203例有充分报告的对照结肠镜检查,45例(22.2%)漏诊息肉,其中26/45例(57.8%)到达了存在漏诊病理的结肠段。在这些病例中,22例(84.6%)肠道准备充分。适应证包括13例(50%)息肉监测、12例(46%)胃肠道症状、1例(4%)息肉筛查。CCE漏诊18例(69.2%)微小息肉和8例(30.8%)直径≥6mm的息肉,其中18/26例(69.2%)为腺瘤。排除不完整的CCE相关因素后,结肠镜检查总的息肉检出率和显著息肉检出率分别为97/184(52.7%)和50/97(51.5%)。CCE总的息肉假阴性率和显著息肉假阴性率分别为26.8%(26/97)和16%(8/50)。重新阅片后,阅片者失误和技术失误分别为20/26(76.9%)和6/26(23.1%)。阅片者失误导致的总的和显著的漏诊息肉率分别为20.6%(20/97)和14%(7/50),技术失误导致的分别为6.2%(6/97)和2%(1/50)。
CCE假阴性率并非微不足道,应在临床决策中予以考虑。