A High-Resolution Microendoscope Improves Esophageal Cancer Screening and Surveillance: Implications for Underserved Global Settings Based on an International Randomized Controlled Trial.

High-resolution microendoscopy (HRME) was shown to improve specificity and reduce unnecessary biopsies when used by academic endoscopists.

高分辨率显微内镜（HRME）在学术内镜医生使用时被证明可以提高特异性并减少不必要的活检。

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.

在这项国际随机对照试验中，我们确定了高分辨率显微内镜（HRME）在真实全球健康环境中的临床影响、效率和性能，涉及不同提供者。

Methods

Individuals undergoing screening or surveillance for ESCN by expert and novice endoscopists were enrolled in China and the United States from diverse clinical settings.

在中国和美国，从不同临床环境中招募了接受食管鳞状细胞癌（ESCN）筛查或监测的个体，由专家和新手内镜医师进行。

Participants were randomized to LCE (standard of care) or LCE + HRME (experimental).

参与者被随机分配到LCE（标准治疗）或LCE + HRME（实验组）。

The primary outcomes were the efficiency and clinical impact of LCE vs LCE + HRME using gold-standard consensus pathology.

主要结果是使用金标准共识病理学评估LCE与LCE + HRME的效率和临床影响。

Results

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.

在916名同意参与的受试者中，有859名（93.8%）在中国招募，36名（3.9%）在美国招募；由于程序或数据不完整，有21名（2.3%）被排除在外。

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.

在筛查组中，有217名参与者被随机分配到LCE组，204名被随机分配到LCE + HRME组；在监测组中，有236名被随机分配到LCE组，238名被随机分配到LCE + HRME组。

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.

HRME提高了筛查效率：诊断效率（肿瘤/总活检）从20.0%（95%置信区间[CI]，12.7-29.2）提高到51.7%（95% CI，32.5-70.6），可能节省了65.2%（95% CI，54.6-74.9）的活检，并且可能使59.7%（95% CI，47.5-71.1）的参与者避免了任何活检。

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.

六名参与者（0.7%）在HRME检查中被内镜医生漏诊（假阴性）；其中，3例为新手医生漏诊的中度或高度异型增生。

Conclusions

A low-cost microendoscope improves the efficiency and clinical impact of ESCN screening and surveillance when combined with LCE.

低成本微型内窥镜与LCE结合使用时，提高了食管鳞状细胞癌筛查和监测的效率和临床影响。

HRME may spare unnecessary biopsies, leading to cost savings in underserved global settings where the disease is prevalent.

HRME可能避免不必要的活检，从而在疾病高发的资源不足的全球环境中节省成本。

(ClinicalTrials.gov, Number NCT02029937).

(ClinicalTrials.gov, 编号 NCT02029937).