A computer-aided polyp detection system in screening and surveillance colonoscopy: an international, multicentre, randomised, tandem trial

IF 23.8 1区医学 Q1 MEDICAL INFORMATICS

Lancet Digital Health Pub Date : 2024-02-21 DOI:10.1016/S2589-7500(23)00242-X

Michiel H J Maas MD , Prof Helmut Neumann MD PhD , Prof Haim Shirin MD , Prof Lior H Katz MD , Ariel A Benson MD , Arslan Kahloon MD , Elsa Soons MD PhD , Rawi Hazzan MD , Marc J Landsman MD , Benjamin Lebwohl MD , Suzanne K Lewis MD , Visvakanth Sivanathan MD , Saowanee Ngamruengphong MD , Harold Jacob MD , Prof Peter D Siersema MD PhD

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引用次数: 0

Abstract

Background

Studies on the effect of computer-aided detection (CAD) in a daily clinical screening and surveillance colonoscopy population practice are scarce. The aim of this study was to evaluate a novel CAD system in a screening and surveillance colonoscopy population.

Methods

This multicentre, randomised, controlled trial was done in ten hospitals in Europe, the USA, and Israel by 31 endoscopists. Patients referred for non-immunochemical faecal occult blood test (iFOBT) screening or surveillance colonoscopy were included. Patients were randomomly assigned to CAD-assisted colonoscopy or conventional colonoscopy; a subset was further randomly assigned to undergo tandem colonoscopy: CAD followed by conventional colonoscopy or conventional colonoscopy followed by CAD. Primary objectives included adenoma per colonoscopy (APC) and adenoma per extraction (APE). Secondary objectives included adenoma miss rate (AMR) in the tandem colonoscopies. The study was registered at ClinicalTrials.gov, NCT04640792.

Findings

A total of 916 patients were included in the modified intention-to-treat analysis: 449 in the CAD group and 467 in the conventional colonoscopy group. APC was higher with CAD compared with conventional colonoscopy (0·70 vs 0·51, p=0·015; 314 adenomas per 449 colonoscopies vs 238 adenomas per 467 colonoscopies; poisson effect ratio 1·372 [95% CI 1·068–1·769]), while showing non-inferiority of APE compared with conventional colonoscopy (0·59 vs 0·66; p<0·001 for non-inferiority; 314 of 536 extractions vs 238 of 360 extractions). AMR in the 127 (61 with CAD first, 66 with conventional colonoscopy first) patients completing tandem colonoscopy was 19% (11 of 59 detected during the second pass) in the CAD first group and 36% (16 of 45 detected during the second pass) in the conventional colonoscopy first group (p=0·024).

Interpretation

CAD increased adenoma detection in non-iFOBT screening and surveillance colonoscopies and reduced adenoma miss rates compared with conventional colonoscopy, without an increase in the resection of non-adenomatous lesions.

Funding

Magentiq Eye.

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筛查和监测结肠镜检查中的计算机辅助息肉检测系统：国际多中心随机串联试验

背景关于计算机辅助检测（CAD）在日常临床筛查和监视结肠镜检查中的应用效果的研究很少。这项研究的目的是评估新型 CAD 系统在筛查和监测结肠镜检查人群中的应用效果。方法这项多中心、随机对照试验是由 31 名内镜医师在欧洲、美国和以色列的 10 家医院进行的。研究对象包括接受非免疫化学粪便潜血试验（iFOBT）筛查或结肠镜监测的患者。患者被随机分配接受 CAD 辅助结肠镜检查或传统结肠镜检查；一部分患者被进一步随机分配接受串联结肠镜检查：子组进一步随机分配接受串联结肠镜检查：先接受 CAD 检查，再接受传统结肠镜检查，或先接受传统结肠镜检查，再接受 CAD 检查。主要目标包括每次结肠镜检查发现的腺瘤（APC）和每次摘除的腺瘤（APE）。次要目标包括串联结肠镜检查中的腺瘤漏检率（AMR）。该研究已在 ClinicalTrials.gov 注册，编号为 NCT04640792。研究结果共有 916 名患者被纳入修改后的意向治疗分析：CAD 组 449 人，传统结肠镜检查组 467 人。与传统结肠镜检查相比，CAD的APC更高（0-70 vs 0-51，p=0-015；每449次结肠镜检查发现314个腺瘤 vs 每467次结肠镜检查发现238个腺瘤；泊松效应比1-372 [95% CI 1-068-1-769]），而与传统结肠镜检查相比，APE显示出非劣性（0-59 vs 0-66；非劣性p<0-001；536次抽取中的314次 vs 360次抽取中的238次）。在完成串联结肠镜检查的 127 名患者中（61 名首先接受 CAD 检查，66 名首先接受传统结肠镜检查），首先接受 CAD 检查组的 AMR 为 19%（59 人中有 11 人在第二次检查中被发现），首先接受传统结肠镜检查组的 AMR 为 36%（45 人中有 16 人在第二次检查中被发现）（p=0-024）。与传统结肠镜检查相比，CAD提高了非iFOBT筛查和监测结肠镜检查的腺瘤检出率，降低了腺瘤漏检率，但非腺瘤病变的切除率并未增加。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Lancet Digital Health Multiple-

CiteScore

41.20

自引率

1.60%

发文量

232

审稿时长

13 weeks

期刊介绍： The Lancet Digital Health publishes important, innovative, and practice-changing research on any topic connected with digital technology in clinical medicine, public health, and global health. The journal’s open access content crosses subject boundaries, building bridges between health professionals and researchers.By bringing together the most important advances in this multidisciplinary field,The Lancet Digital Health is the most prominent publishing venue in digital health. We publish a range of content types including Articles,Review, Comment, and Correspondence, contributing to promoting digital technologies in health practice worldwide.