Protano Marion-Anna, Xu Hong, Wang Guiqi, Polydorides Alexandros D, Dawsey Sanford M, Cui Junsheng, Xue Liyan, Zhang Fan, Quang Timothy, Pierce Mark C, Shin Dongsuk, Schwarz Richard A, Bhutani Manoop S, Lee Michelle, Parikh Neil, Hur Chin, Xu Weiran, Moshier Erin, Godbold James, Mitcham Josephine, Hudson Courtney, Richards-Kortum Rebecca R, Anandasabapathy Sharmila
Division of Gastroenterology, The Mount Sinai Medical Center, New York, NY.
Department of Endoscopy, The First Hospital of Jilin University, Changchun, Jilin, China.
Gastroenterology. 2015 Aug;149(2):321-329. doi: 10.1053/j.gastro.2015.04.055. Epub 2015 May 14.
BACKGROUND & AIMS: Esophageal squamous cell neoplasia has a high mortality rate as a result of late detection. In high-risk regions such as China, screening is performed by Lugol's chromoendoscopy (LCE). LCE has low specificity, resulting in unnecessary tissue biopsy with a subsequent increase in procedure cost and risk. The purpose of this study was to evaluate the accuracy of a novel, low-cost, high-resolution microendoscope (HRME) as an adjunct to LCE.
In this prospective trial, 147 consecutive high-risk patients were enrolled from 2 US and 2 Chinese tertiary centers. Three expert and 4 novice endoscopists performed white-light endoscopy followed by LCE and HRME. All optical images were compared with the gold standard of histopathology.
By using a per-biopsy analysis, the sensitivity of LCE vs LCE + HRME was 96% vs 91% (P = .0832), specificity was 48% vs 88% (P < .001), positive predictive value was 22% vs 45% (P < .0001), negative predictive value was 98% vs 98% (P = .3551), and overall accuracy was 57% vs 90% (P < .001), respectively. By using a per-patient analysis, the sensitivity of LCE vs LCE + HRME was 100% vs 95% (P = .16), specificity was 29% vs 79% (P < .001), positive predictive value was 32% vs 60%, 100% vs 98%, and accuracy was 47% vs 83% (P < .001). With the use of HRME, 136 biopsies (60%; 95% confidence interval, 53%-66%) could have been spared, and 55 patients (48%; 95% confidence interval, 38%-57%) could have been spared any biopsy.
In this trial, HRME improved the accuracy of LCE for esophageal squamous cell neoplasia screening and surveillance. HRME may be a cost-effective optical biopsy adjunct to LCE, potentially reducing unnecessary biopsies and facilitating real-time decision making in globally underserved regions. ClinicalTrials.gov, NCT 01384708.
由于发现较晚，食管鳞状细胞瘤具有较高的死亡率。在中国等高风险地区，通过卢戈氏染色内镜检查（LCE）进行筛查。LCE特异性较低，导致不必要的组织活检，进而增加了检查成本和风险。本研究的目的是评估一种新型、低成本、高分辨率的微型内镜（HRME）作为LCE辅助手段的准确性。
在这项前瞻性试验中，从2家美国和2家中国三级中心连续纳入了147例高危患者。3名专家内镜医师和4名新手内镜医师先进行白光内镜检查，随后进行LCE和HRME。所有光学图像均与组织病理学金标准进行比较。
采用每次活检分析，LCE与LCE + HRME的敏感性分别为96%和91%（P = 0.0832），特异性分别为48%和88%（P < 0.001），阳性预测值分别为22%和45%（P < 0.0001），阴性预测值分别为98%和98%（P = 0.3551），总体准确率分别为57%和90%（P < 0.001）。采用每名患者分析，LCE与LCE + HRME的敏感性分别为100%和95%（P = 0.16），特异性分别为29%和79%（P < 0.001），阳性预测值分别为32%和60%、100%和98%，准确率分别为47%和83%（P < 0.001）。使用HRME后，可避免136次活检（60%；95%置信区间，53%-66%），55例患者（48%；95%置信区间，38%-57%）可避免任何活检。
在本试验中，HRME提高了LCE对食管鳞状细胞瘤筛查和监测的准确性。HRME可能是一种具有成本效益的LCE光学活检辅助手段，有可能减少不必要的活检，并在全球医疗服务不足地区促进实时决策。ClinicalTrials.gov，NCT 01384708。
