Liu Jing, Zhou Ruchen, Liu Chengxia, Liu Haiyan, Cui Zhenqin, Guo Zhuang, Zhao Weidong, Zhong Xiaoqin, Zhang Xiaodong, Li Jing, Wang Shihuan, Xing Li, Zhao Yusha, Ma Ruiguang, Ni Jiekun, Li Zhen, Li Yanqing, Zuo Xiuli
Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.
Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China.
JAMA Netw Open. 2025 Jan 2;8(1):e2457241. doi: 10.1001/jamanetworkopen.2024.57241.
High-quality colonoscopy reduces the risks of colorectal cancer by increasing the adenoma detection rate. Routine use of an automatic quality control system (AQCS) to assist in colorectal adenoma detection should be considered.
To evaluate the effect of an AQCS on the adenoma detection rate among colonoscopists who were moderate- and low-level detectors during routine colonoscopy.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter, single-blind, randomized clinical trial was conducted at 6 centers in China from August 1, 2021, to September 30, 2022. Data were analyzed from March 1 to June 30, 2023. Individuals aged 18 to 80 years were enrolled. Exclusion criteria were a history of inflammatory bowel disease, advanced colorectal cancer, and polyposis syndromes; known colorectal polyps without complete removal previously; a history of colorectal surgery; known stenosis or obstruction with contraindication for biopsy or prior failed colonoscopy; pregnancy or lactation; and refusal to participate. Intention-to-treat and per-protocol analysis was used.
Standard colonoscopy or AQCS-assisted colonoscopy.
Adenoma detection rate.
A total of 1254 participants (mean [SD] age, 51.21 [12.10] years; 674 [53.7%] male) were randomized (627 standard colonoscopy, 627 AQCS-assisted colonoscopy). Intention-to-treat analysis showed a significantly higher adenoma detection rate in the AQCS-assisted group vs standard colonoscopy group (32.7% vs 22.6%; relative risk [RR], 1.60; 95% CI, 1.23-2.09; P < .001). The adenoma detection rates were significantly higher in the AQCS group when considering pathology (nonadvanced adenomas, 30.1% vs 21.2%; RR, 1.52; 95% CI, 1.16-1.99; P = .002), and morphology (flat or sessile, 29.3% vs 20.4%, RR, 1.52; 95% CI, 1.16-2.00; P = .003). Use of AQCS significantly increased the adenoma detection rate of both the lower-level detectors (30.0% vs 20.0%; RR, 1.71; 95% CI, 1.24-2.35; P = .001) and the medium-level detectors (38.1% vs 27.7%; RR, 1.61; 95% CI, 1.07-2.43; P = .02). Similar increases were found for adenoma detection rates in the academic and nonacademic centers (academic: 29.3% vs 20.8%; RR, 1.58; 95% CI, 1.10-2.29; P = .01; nonacademic: 36.1% vs 24.5%; RR, 1.74; 95% CI, 1.23-2.46; P = .002). The number of adenomas per colonoscopy was significantly higher in the AQCS-assisted group (0.86 vs 0.48; RR, 1.50; 95% CI, 1.17-1.91; P = .001). The mean withdrawal time without intervention was slightly increased with AQCS assistance (6.78 vs 6.46 minutes; RR, 1.38; 95% CI, 1.26-1.52; P < .001). No serious adverse events were reported.
In this randomized clinical trial, AQCS assistance during routine colonoscopy increased adenoma detection rates and several related polyp parameters compared with standard colonoscopy in the lower- and medium-level detectors in academic and nonacademic settings. Routine use of AQCS to assist in colorectal adenoma detection and quality improvement should be considered.
ClinicalTrials.gov Identifier: NCT04901130.
高质量结肠镜检查通过提高腺瘤检出率降低结直肠癌风险。应考虑常规使用自动质量控制系统（AQCS）辅助结直肠腺瘤检测。
评估AQCS对常规结肠镜检查中中低水平检测者腺瘤检出率的影响。
设计、设置和参与者：这项多中心、单盲、随机临床试验于2021年8月1日至2022年9月30日在中国的6个中心进行。2023年3月1日至6月30日进行数据分析。纳入年龄在18至80岁的个体。排除标准包括炎症性肠病病史、晚期结直肠癌和息肉病综合征；既往有未完全切除的已知结直肠息肉；有结直肠手术史；已知有狭窄或梗阻且有活检禁忌或先前结肠镜检查失败；妊娠或哺乳期；以及拒绝参与。采用意向性分析和符合方案分析。
标准结肠镜检查或AQCS辅助结肠镜检查。
腺瘤检出率。
共1254名参与者（平均[标准差]年龄，51.21[12.10]岁；674名[53.7%]男性）被随机分组（627名接受标准结肠镜检查，627名接受AQCS辅助结肠镜检查）。意向性分析显示，AQCS辅助组的腺瘤检出率显著高于标准结肠镜检查组（32.7%对22.6%；相对风险[RR]，1.60；95%置信区间，1.23 - 2.09；P <.001）。考虑病理情况（非高级腺瘤，30.1%对21.2%；RR，1.52；95%置信区间，1.16 - 1.99；P =.002）和形态（扁平或无蒂，29.3%对20.4%，RR，1.52；95%置信区间，1.16 - 2.00；P =.003）时，AQCS组的腺瘤检出率显著更高。使用AQCS显著提高了低水平检测者（30.0%对20.0%；RR，1.71；95%置信区间，1.24 - 2.35；P =.001）和中等水平检测者（38.1%对27.7%；RR，1.61；95%置信区间，1.07 - 2.43；P =.02）的腺瘤检出率。学术中心和非学术中心的腺瘤检出率也有类似增加（学术中心：29.3%对20.8%；RR，1.58；95%置信区间，1.10 - 2.29；P =.01；非学术中心：36.1%对24.5%；RR，1.74；95%置信区间，1.23 - 2.46；P =.002）。AQCS辅助组每次结肠镜检查的腺瘤数量显著更多（0.86对0.48；RR，1.50；95%置信区间，1.17 - 1.91；P =.001）。在AQCS辅助下，无干预的平均退镜时间略有增加（6.78对6.46分钟；RR，1.38；95%置信区间，1.26 - 1.52；P <.001）。未报告严重不良事件。
在这项随机临床试验中，与学术和非学术环境中的中低水平检测者进行标准结肠镜检查相比，常规结肠镜检查期间AQCS辅助提高了腺瘤检出率以及几个相关息肉参数。应考虑常规使用AQCS辅助结直肠腺瘤检测和质量改进。
ClinicalTrials.gov标识符：NCT04901130
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