高分辨率显微内窥镜改善了食管癌筛查和监测：基于一项国际随机对照试验对全球服务不足地区的影响

IF 25.7 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gastroenterology Pub Date : 2024-10-29 DOI:10.1053/j.gastro.2024.10.025

Mimi C. Tan, Zhengqi Li, Kalpesh K. Patel, Fan Zhang, Xinying Yu, Xueshan Wang, Daniel G. Rosen, Sanford M. Dawsey, Liyan Xue, Chin Hur, Richard A. Schwarz, Imran Vohra, Yubo Tang, Mengfen Wu, Tao Wang, Jennifer Carns, Hong Xu, Rebecca R. Richards-Kortum, Guiqi Wang, Sharmila Anandasabapathy

{"title":"高分辨率显微内窥镜改善了食管癌筛查和监测：基于一项国际随机对照试验对全球服务不足地区的影响","authors":"Mimi C. Tan, Zhengqi Li, Kalpesh K. Patel, Fan Zhang, Xinying Yu, Xueshan Wang, Daniel G. Rosen, Sanford M. Dawsey, Liyan Xue, Chin Hur, Richard A. Schwarz, Imran Vohra, Yubo Tang, Mengfen Wu, Tao Wang, Jennifer Carns, Hong Xu, Rebecca R. Richards-Kortum, Guiqi Wang, Sharmila Anandasabapathy","doi":"10.1053/j.gastro.2024.10.025","DOIUrl":null,"url":null,"abstract":"<h3>Background and Aims</h3>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.<h3>Methods</h3>Subjects undergoing screening or surveillance for ESCN by expert and novice endoscopists were enrolled in China and the U.S. from diverse clinical settings. Subjects were randomized to LCE (standard-of-care) or LCE+HRME (experimental). Primary outcomes were <em>efficiency</em> and <em>clinical impact</em> of LCE vs. LCE+HRME, using gold-standard, consensus pathology.<h3>Results</h3>Among 916 consented subjects, 859 (93.8%) were recruited in China and 36 (3.9%) in the U.S.; 21 (2.3%) were excluded due to incomplete procedure or data. In the screening arm, 217 subjects were randomized to LCE, 204 to LCE+HRME; in the surveillance arm, 236 were randomized to LCE, 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 subjects potentially spared <em>any</em> biopsy. Six subjects (0.7%) had neoplasia missed by the endoscopist on HRME (false negatives); of these, 3 were moderate or high-grade dysplasia missed by novices.<h3>Conclusion</h3>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. <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, Number NCT02029937.","PeriodicalId":12590,"journal":{"name":"Gastroenterology","volume":"13 1","pages":""},"PeriodicalIF":25.7000,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A HIGH-RESOLUTION MICROENDOSCOPE IMPROVES ESOPHAGEAL CANCER SCREENING AND SURVEILLANCE: IMPLICATIONS FOR UNDERSERVED GLOBAL SETTINGS BASED ON AN INTERNATIONAL, RANDOMIZED CONTROLLED TRIAL\",\"authors\":\"Mimi C. Tan, Zhengqi Li, Kalpesh K. Patel, Fan Zhang, Xinying Yu, Xueshan Wang, Daniel G. Rosen, Sanford M. Dawsey, Liyan Xue, Chin Hur, Richard A. Schwarz, Imran Vohra, Yubo Tang, Mengfen Wu, Tao Wang, Jennifer Carns, Hong Xu, Rebecca R. Richards-Kortum, Guiqi Wang, Sharmila Anandasabapathy\",\"doi\":\"10.1053/j.gastro.2024.10.025\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3>Background and Aims</h3>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.<h3>Methods</h3>Subjects undergoing screening or surveillance for ESCN by expert and novice endoscopists were enrolled in China and the U.S. from diverse clinical settings. Subjects were randomized to LCE (standard-of-care) or LCE+HRME (experimental). Primary outcomes were <em>efficiency</em> and <em>clinical impact</em> of LCE vs. LCE+HRME, using gold-standard, consensus pathology.<h3>Results</h3>Among 916 consented subjects, 859 (93.8%) were recruited in China and 36 (3.9%) in the U.S.; 21 (2.3%) were excluded due to incomplete procedure or data. In the screening arm, 217 subjects were randomized to LCE, 204 to LCE+HRME; in the surveillance arm, 236 were randomized to LCE, 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 subjects potentially spared <em>any</em> biopsy. Six subjects (0.7%) had neoplasia missed by the endoscopist on HRME (false negatives); of these, 3 were moderate or high-grade dysplasia missed by novices.<h3>Conclusion</h3>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. <span><span>ClinicalTrials.gov</span><svg aria-label=\\\"Opens in new window\\\" focusable=\\\"false\\\" height=\\\"20\\\" viewbox=\\\"0 0 8 8\\\"><path d=\\\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\\\"></path></svg></span>, Number NCT02029937.\",\"PeriodicalId\":12590,\"journal\":{\"name\":\"Gastroenterology\",\"volume\":\"13 1\",\"pages\":\"\"},\"PeriodicalIF\":25.7000,\"publicationDate\":\"2024-10-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1053/j.gastro.2024.10.025\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1053/j.gastro.2024.10.025","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

背景和目的基于Lugol色内镜（LCE）的食管鳞状细胞瘤（ESCN）检测因特异性低而受到限制。高分辨率显微内镜（HRME）被证明可提高特异性，减少学术内镜医师不必要的活检。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在真实的全球卫生环境中对不同医疗服务提供者的临床影响、效率和性能。方法在中国和美国，我们从不同的临床环境中招募了由内镜专家和新手进行ESCN筛查或监测的受试者。受试者被随机分配到LCE（标准护理）或LCE+HRME（实验）。结果在916名同意的受试者中，859人（93.8%）在中国招募，36人（3.9%）在美国招募；21人（2.3%）因程序或数据不完整而被排除。在筛查组中，217名受试者被随机分配到LCE，204名受试者被随机分配到LCE+HRME；在监测组中，236名受试者被随机分配到LCE，238名受试者被随机分配到LCE+HRME。HRME提高了筛查效率：诊断率（肿瘤性/活检总数）从20.0%（95%置信区间[CI] 12.7-29.2%）提高到51.7%（95% CI 32.5-70.6%），其中65.2%（95% CI 54.6-74.9%）的活检可能被挽救，59.7%（95% CI 47.5-71.1%）的受试者可能免于任何活检。6名受试者（0.7%）的内镜医师在进行HRME检查时漏诊了肿瘤（假阴性）；其中3例是新手漏诊的中度或高度发育不良。HRME可避免不必要的活组织检查，从而在该病流行、服务不足的全球环境中节约成本。ClinicalTrials.gov, Number NCT02029937.

本文章由计算机程序翻译，如有差异，请以英文原文为准。

A HIGH-RESOLUTION MICROENDOSCOPE IMPROVES ESOPHAGEAL CANCER SCREENING AND SURVEILLANCE: IMPLICATIONS FOR UNDERSERVED GLOBAL SETTINGS BASED ON AN INTERNATIONAL, RANDOMIZED CONTROLLED TRIAL

查看原文本刊更多论文

A HIGH-RESOLUTION MICROENDOSCOPE IMPROVES ESOPHAGEAL CANCER SCREENING AND SURVEILLANCE: IMPLICATIONS FOR UNDERSERVED GLOBAL SETTINGS BASED ON AN INTERNATIONAL, RANDOMIZED CONTROLLED TRIAL

Background and 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.

Methods

Subjects undergoing screening or surveillance for ESCN by expert and novice endoscopists were enrolled in China and the U.S. from diverse clinical settings. Subjects were randomized to LCE (standard-of-care) or LCE+HRME (experimental). Primary outcomes were efficiency and clinical impact of LCE vs. LCE+HRME, using gold-standard, consensus pathology.

Results

Among 916 consented subjects, 859 (93.8%) were recruited in China and 36 (3.9%) in the U.S.; 21 (2.3%) were excluded due to incomplete procedure or data. In the screening arm, 217 subjects were randomized to LCE, 204 to LCE+HRME; in the surveillance arm, 236 were randomized to LCE, 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 subjects potentially spared any biopsy. Six subjects (0.7%) had neoplasia missed by the endoscopist on HRME (false negatives); of these, 3 were moderate or high-grade dysplasia missed by novices.

Conclusion

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.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Gastroenterology 医学-胃肠肝病学

CiteScore

45.60

自引率

2.40%

发文量

4366

审稿时长

26 days

期刊介绍： Gastroenterology is the most prominent journal in the field of gastrointestinal disease. It is the flagship journal of the American Gastroenterological Association and delivers authoritative coverage of clinical, translational, and basic studies of all aspects of the digestive system, including the liver and pancreas, as well as nutrition. Some regular features of Gastroenterology include original research studies by leading authorities, comprehensive reviews and perspectives on important topics in adult and pediatric gastroenterology and hepatology. The journal also includes features such as editorials, correspondence, and commentaries, as well as special sections like "Mentoring, Education and Training Corner," "Diversity, Equity and Inclusion in GI," "Gastro Digest," "Gastro Curbside Consult," and "Gastro Grand Rounds." Gastroenterology also provides digital media materials such as videos and "GI Rapid Reel" animations. It is abstracted and indexed in various databases including Scopus, Biological Abstracts, Current Contents, Embase, Nutrition Abstracts, Chemical Abstracts, Current Awareness in Biological Sciences, PubMed/Medline, and the Science Citation Index.