Tan Mimi C, Li Zhengqi, Patel Kalpesh K, Zhang Fan, Yu Xinying, Wang Xueshan, Rosen Daniel G, Dawsey Sanford M, Xue Liyan, Hur Chin, Schwarz Richard A, Vohra Imran, Tang Yubo, Wu Mengfen, Wang Tao, Carns Jennifer, Xu Hong, Richards-Kortum Rebecca R, Wang Guiqi, Anandasabapathy Sharmila
Section of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, Texas; Global Programs, Baylor College of Medicine, Houston, Texas.
Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Gastroenterology. 2025 Mar;168(3):496-507.e3. doi: 10.1053/j.gastro.2024.10.025. Epub 2024 Oct 29.
BACKGROUND & AIMS: Lugol's chromoendoscopy (LCE)-based detection of esophageal squamous cell neoplasia (ESCN) is limited by low specificity. High-resolution microendoscopy (HRME) was shown to improve specificity and reduce unnecessary biopsies when used by academic endoscopists. In this international randomized controlled trial, we determined the clinical impact, efficiency, and performance of HRME in true global health contexts with a range of providers.
Individuals undergoing screening or surveillance for ESCN by expert and novice endoscopists were enrolled in China and the United States from diverse clinical settings. Participants were randomized to LCE (standard of care) or LCE + HRME (experimental). The primary outcomes were the efficiency and clinical impact of LCE vs LCE + HRME using gold-standard consensus pathology.
Among 916 consented participants, 859 (93.8%) were recruited in China and 36 (3.9%) in the United States; 21 (2.3%) were excluded due to incomplete procedure or data. In the screening arm, 217 participants were randomized to LCE and 204 to LCE + HRME; in the surveillance arm, 236 were randomized to LCE and 238 to LCE + HRME. HRME increased efficiency in screening: diagnostic yield (neoplastic/total biopsies) improved from 20.0% (95% confidence interval [CI], 12.7-29.2) to 51.7% (95% CI, 32.5-70.6) with 65.2% (95% CI, 54.6-74.9) of biopsies potentially saved and 59.7% (95% CI, 47.5-71.1) of participants potentially spared any biopsy. Six participants (0.7%) had neoplasia missed by the endoscopist on HRME (false negatives); of these, 3 were moderate or high-grade dysplasia missed by novices.
A low-cost microendoscope improves the efficiency and clinical impact of ESCN screening and surveillance when combined with LCE. HRME may spare unnecessary biopsies, leading to cost savings in underserved global settings where the disease is prevalent. (ClinicalTrials.gov, Number NCT02029937).
基于卢戈氏染色内镜检查（LCE）检测食管鳞状细胞肿瘤（ESCN）的特异性较低。高分辨率显微内镜检查（HRME）在学术内镜医师使用时可提高特异性并减少不必要的活检。在这项国际随机对照试验中，我们确定了HRME在不同医疗服务提供者参与的真实全球卫生环境中的临床影响、效率和性能。
在中国和美国，从不同临床环境中招募接受专家和新手内镜医师进行ESCN筛查或监测的个体。参与者被随机分为LCE组（护理标准）或LCE + HRME组（试验组）。主要结局是使用金标准共识病理学比较LCE与LCE + HRME的效率和临床影响。
在916名同意参与的参与者中，859名（93.8%）在中国招募，36名（3.9%）在美国招募；21名（2.3%）因操作或数据不完整被排除。在筛查组中，217名参与者被随机分配至LCE组，204名被分配至LCE + HRME组；在监测组中，236名被随机分配至LCE组，238名被分配至LCE + HRME组。HRME提高了筛查效率：诊断率（肿瘤性/总活检数）从20.0%（95%置信区间[CI]，12.7 - 29.2）提高至51.7%（95%CI，32.5 - 70.6），可能节省65.2%（95%CI，54.6 - 74.9）的活检数，59.7%（95%CI，47.5 - 71.1）的参与者可能无需进行任何活检。6名参与者（0.7%）在HRME检查中被内镜医师漏诊为肿瘤（假阴性）；其中，3名是新手漏诊的中度或高度发育异常。
低成本显微内镜与LCE联合使用时可提高ESCN筛查和监测的效率及临床影响。HRME可能避免不必要的活检，在该疾病流行的全球医疗资源匮乏地区可节省成本。（ClinicalTrials.gov注册号：NCT02029937）
