食管海绵细胞学在食管癌高发县食管癌筛查中的应用研究

Application of esophageal sponge cytology to esophageal carcinoma screening in high‑incidence districts

摘要:

目的 探讨食管海绵细胞学应用于食管癌高发县食管癌筛查中的安全性、可行性和准确性。方法 对2021年5月至2022年6月在涟水县人民医院就诊的有食管癌高危因素、年龄40~75岁的人群进行食管癌机会性筛查，使用国内自主研发的新型食管细胞收集器进行食管海绵细胞学采样并送细胞病理学分析（非典型鳞状细胞及更严重的病变被定义为食管海绵细胞学阳性），完成细胞学采样后紧接着行胃镜检查，对内镜下所有可疑区域取活检行组织病理学检查。胃镜检查、活检组织病理学、食管海绵细胞学两两互盲。观察指标包括：采样过程中的不良反应发生情况、受试者耐受性，采样质量，以及以胃镜检查结果+活检组织病理学结果作为金标准的食管海绵细胞学检查的诊断准确性。结果 研究期间共有1 590名受试者完成研究。在食管海绵细胞学检查采样过程中，未见严重不良反应，不良反应主要表现为采集期间呕吐［0.31%（5/1 590）］和采集后喉咙不适［2.45%（39/1 590）］，均能自行缓解。对于采样过程，大部分受试者耐受性良好，表示可以接受［98.62%（1 568/1 590）］。取样后观察，1 526名（95.97%）受试者的海绵材料完全膨胀，达到采样质量良好标准。数字病理系统扫描分析显示，1 590名受试者的采样细胞数在（2.01~4.00）×106个，中位采样细胞数3.48×106个，能够满足细胞学结果的判读要求。以食管海绵细胞学阳性诊断食管癌（食管高级别上皮内瘤变、食管鳞癌、食管胃交界部腺癌）的敏感度为98.57%（69/70）、特异度为91.51%（1 391/1 520）、阳性预测值为34.85%（69/198）、阴性预测值为99.93%（1 391/1 392）、准确率为91.82%（1 460/1 590）。结论 食管海绵细胞学可应用于食管癌高发县的食管癌筛查，是一种简单方便、安全有效且人群接受度较高的食管癌筛查方法。

Abstract:

Objective To investigate the safety, feasibility and accuracy of esophageal sponge cytology in esophageal carcinoma screening in high‑incidence districts. Methods Opportunistic screening for esophageal carcinoma was conducted on individuals aged 40‑75 years with high‑risk factors for esophageal carcinoma and visited out‑patient clinic in Lianshui People""s Hospital from May 2021 to June 2022. A new esophageal cell collector independently developed in China was used for esophageal sponge cytology sampling followed by cytopathological analysis. Atypical squamous cells or more severe lesions were defined as positive esophageal sponge cytology. Then gastroscopy was performed, and all suspicious areas under the endoscopy were biopsied for histopathological examination. Gastroscopy, biopsy histopathology and esophageal sponge cytology were conducted blindly in pairs. Outcome measures included adverse reactions during sampling, subject tolerability (using a visual simulation score), sampling quality, and diagnostic efficacy of esophageal sponge cytology using gastroscopy plus biopsy histopathology as the gold standard. Results A total of 1 590 patients completed the screening program. During esophageal sponge cytology sampling, no serious adverse events were observed, and the adverse reactions were mainly manifested as vomiting during sampling [0.31% (5/1 590)] and sore throat after sampling [2.45% (39/1 590)], all of which resolved spontaneously without further medical intervention. The majority of subjects [98.62% (1 568/1 590)] reported good tolerance during the procedure. After sampling, 1 526 (95.97%) subjects had completely expanded sponge material, meeting the standard of good sampling quality. The scanning analysis of the digital pathology system showed that the number of sampled cells in 1 590 subjects ranged (2.01‑4.00)×106, with a median of 3.48×106 cells, which could meet the requirements for interpreting cytological results. Using the positive esophageal sponge cytology for the diagnosis of esophageal carcinoma including high‑grade intraepithelial neoplasia, esophageal squamous cell carcinoma and adenocarcinoma of esophagogastric junction, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 98.57% (69/70), 91.51% (1 391/1 520), 34.85% (69/198), 99.93% (1 391/1 392), and 91.82% (1 460/1 590), respectively. Conclusion Esophageal sponge cytology presents promising diagnostic efficacy for esophageal carcinoma screening, offering a simple, safe, convenient, and effective approach in high‑incidence esophageal carcinoma regions.