计算机辅助息肉检测系统在结肠镜筛查和监测中的应用：一项国际多中心随机平行对照试验。

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

机构信息

Department of Gastroenterology & Hepatology, Radboud University Medical Center, Nijmegen, Netherlands.

University Medical Center Mainz, Interventional Endoscopy Center, I Medizinische Klinik und Poliklinik, Mainz, Germany.

出版信息

Lancet Digit Health. 2024 Mar;6(3):e157-e165. doi: 10.1016/S2589-7500(23)00242-X.

DOI:10.1016/S2589-7500(23)00242-X

PMID:38395537

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.

摘要

背景

关于计算机辅助检测（CAD）在日常临床筛查和监测结肠镜检查人群中的应用效果的研究较为匮乏。本研究旨在评估一种新型 CAD 系统在筛查和监测结肠镜检查人群中的应用效果。

方法

该多中心、随机、对照试验由 31 名内镜医生在欧洲、美国和以色列的 10 家医院进行。纳入非免疫化学粪便潜血试验（iFOBT）筛查或监测结肠镜检查的患者。患者被随机分配至 CAD 辅助结肠镜检查或常规结肠镜检查；其中一部分患者进一步被随机分配行串联结肠镜检查：CAD 后行常规结肠镜检查或常规结肠镜检查后行 CAD。主要终点包括每例结肠镜检查的腺瘤数（APC）和每例提取的腺瘤数（APE）。次要终点包括串联结肠镜检查中的腺瘤漏诊率（AMR）。该研究在 ClinicalTrials.gov 注册，编号为 NCT04640792。

结果

共有 916 例患者纳入改良意向治疗分析：CAD 组 449 例，常规结肠镜组 467 例。与常规结肠镜检查相比，CAD 组的 APC 更高（0.70 比 0.51，p=0.015；449 例结肠镜检查中有 314 个腺瘤，467 例结肠镜检查中有 238 个腺瘤；泊松效应比 1.372[95%CI 1.068-1.769]），而 APE 与常规结肠镜检查相比无差异（0.59 比 0.66；非劣效性 p<0.001；536 次提取中有 314 个腺瘤，360 次提取中有 238 个腺瘤）。完成串联结肠镜检查的 127 例患者（61 例先接受 CAD，66 例先接受常规结肠镜检查）中，CAD 组的 AMR 为 19%（第二次检查时发现 11 例），而常规结肠镜组为 36%（第二次检查时发现 16 例）（p=0.024）。