Antonelli Giulio, Desideri Federico, Scarozza Patrizio, Andrisani Gianluca, Zerboni Giulia, Furnari Manuele, Bevilacqua Nicolò, Cossignani Marta, Di Fonzo Michela, Cereatti Fabrizio, Navazzotti Giulia, Antenucci Claudia, Di Matteo Francesco Maria, Bevivino Gerolamo, Caruso Anna, Spadaccini Marco, Schiavone Sara, Grossi Cristina, Rizkala Tommy, Comberlato Michele, Bretthauer Michael, Sharma Prateek, Von Renteln Daniel, Rex Douglas K, Correale Loredana, Repici Alessandro, Mori Yuichi, Iacopini Federico, Hassan Cesare
Gastroenterology and Digestive Endoscopy Unit, Ospedale dei Castelli Hospital, Rome, Italy.
Department of Gastroenterology, San Maurizio Hospital, Bolzano, Italy.
Lancet Gastroenterol Hepatol. 2025 Oct;10(10):915-923. doi: 10.1016/S2468-1253(25)00140-2.
Guidelines recommend leaving in situ rectosigmoid polyps diagnosed during colonoscopy that are 5 mm or smaller if the endoscopist optically predicts them to be non-neoplastic. However, no randomised controlled trial has been done to examine the efficacy and safety of this strategy.
This open-label, multicentre, non-inferiority, randomised controlled trial enrolled adults age 18 years or older undergoing colonoscopy for screening, surveillance, or clinical indications across four Italian centres. Eligible patients were randomised 1:1 (with stratification by patient sex, age, and previous adenoma removal) via a central web-based system, to either the leave-in-situ group, in which endoscopists could leave non-neoplastic lesions in place after optical diagnosis, or the resect-all group, in which all detected polyps were systematically removed, regardless of optical diagnosis. Patients and endoscopists were not masked to group allocation but pathologists and investigators assessing outcomes were masked. All procedures in both groups were done with the assistance of a computer-aided detection and diagnosis system. Endoscopists optically diagnosed lesions through a combination of white light, blue light, and computer-aided detection. The primary outcome was the adenoma detection rate (ADR), defined as the proportion of participants with at least one adenoma detected (per-patient analysis), assessed by intention-to-treat, to determine whether the leave-in-situ strategy was non-inferior to the resect-all approach, with an absolute 10% non-inferiority margin. This trial was registered with ClinicalTrials.gov (NCT05500248) and is completed.
Between Oct 1, 2022, and April 30, 2024, 1147 patients were recruited and 895 patients (507 [57%] females, 388 [43%] males, mean age 61·1 years [SD 9·8]) were randomly assigned to either the leave-in-situ group (n=441) or resect-all group (n=454). 197 adenomas or colorectal cancers were detected in the leave-in-situ group and 211 in the resect-all group; the ADR was 44·7% (95% CI 40·4 to 49·5) in the leave-in-situ group and 46·5% (41·8 to 51·2) in the resect-all group (absolute difference -1·8 percentage points, 95% CI -8·9 to 4·9; p=0·013). No colonoscopy-related complications, including perforation and bleeding, were reported in either group.
The leave-in-situ strategy through optical diagnosis with computer-assisted diagnosis support does not reduce oncological safety of colonoscopy, as measured by ADR. By reducing unnecessary polypectomies, this strategy could be considered as an attractive option in colonoscopy practice.
European Society of Gastrointestinal Endoscopy.
指南建议，如果内镜医师通过光学检查预测结肠镜检查时诊断出的直肠乙状结肠息肉为非肿瘤性，且息肉大小为5毫米或更小，则可将其留在原位。然而，尚未进行随机对照试验来检验该策略的有效性和安全性。
这项开放标签、多中心、非劣效性随机对照试验纳入了年龄在18岁及以上、因筛查、监测或临床指征在意大利四个中心接受结肠镜检查的成年人。符合条件的患者通过基于网络的中央系统按1:1随机分组（按患者性别、年龄和既往腺瘤切除情况分层），分为留原位组，即内镜医师在光学诊断后可将非肿瘤性病变留在原位；以及全部切除组，即无论光学诊断结果如何，所有检测到的息肉均被系统切除。患者和内镜医师不了解分组情况，但病理学家和评估结果的研究人员对此不知情。两组的所有操作均在计算机辅助检测和诊断系统的辅助下进行。内镜医师通过白光、蓝光和计算机辅助检测相结合的方式对病变进行光学诊断。主要结局是腺瘤检出率（ADR），定义为至少检测到一个腺瘤的参与者比例（按患者分析），采用意向性分析进行评估，以确定留原位策略是否不劣于全部切除方法，非劣效性界值为绝对10%。该试验已在ClinicalTrials.gov注册（NCT05500248），现已完成。
在2022年10月1日至2024年4月30日期间，共招募了1147例患者，895例患者（507例[57%]为女性，388例[43%]为男性，平均年龄61.1岁[标准差9.8]）被随机分配至留原位组（n = 441）或全部切除组（n = 454）。留原位组检测到197例腺瘤或结直肠癌，全部切除组检测到211例；留原位组的ADR为44.7%（95%置信区间40.4至49.5），全部切除组为46.5%（41.8至51.2）（绝对差异-1.8个百分点，95%置信区间-8.9至4.9；p = 0.013）。两组均未报告与结肠镜检查相关的并发症，包括穿孔和出血。
在计算机辅助诊断支持下通过光学诊断的留原位策略，按ADR衡量，不会降低结肠镜检查的肿瘤学安全性。通过减少不必要的息肉切除术，该策略可被视为结肠镜检查实践中的一个有吸引力的选择。
欧洲胃肠内镜学会。
