Abstract: Comparison of image enhanced endoscopy and traditional white light endoscopy in the colorectal polyp detection: A randomized clinical trial        XU En-pan*, QI Zhi-peng, HE Dong-li，et al. *Department of Endoscopy Center, Zhongshan Hospital, Fudan University; Shanghai Center of Engineering Technology, Diagnosis and Treatment in Endoscopy，Shanghai 200032, China
Corresponding author：ZHONG Yun-shi, E-mail: zhong.yunshi@zs-hospital.sh.cn
XU En-pan and QI Zhi-peng are the first authors who contributed equally to the article
Abstract    Objective    To compare and evaluate the adenoma detection rate between image-enhanced endoscopy (IEE) and traditional white light endoscopy (WLE). Methods    From October 2019 to June 2020, a total of 1522 patients were selected from Zhongshan Hospital, Fudan University and Central Hospital of Xuhui District, Shanghai (1253 cases), Xiamen Branch, Zhongshan Hospital, Fudan University (62 cases) and Rongcheng Hospital of Traditional Chinese (207 cases). The patients were randomly divided into two groups by central stratified randomization method, and the effective cases were screened. The IEE group entered with white light mode, and the enhancement mode was used to withdraw the colonoscopy (748 effective cases were finally included). The WLE group entered and withdrew with white light mode (727 effective cases were finally included). Comparison and analysis of ADR, polyp detection rate, average number of adenomas, size, location, number, morphology, withdrawal time, and other indicators of the two groups were performed. According to different enhancement modes, the enhancement components were divided into NBI group and LCI group for subgroup analysis. Results    The overall ADR difference between IEE group and WLE group was not statistically significant (24.9% vs. 22.1%, χ2=1.517, P=0.218), but in patients under 50 years of age, especially those for screening purposes, IEE group ADR was higher than that of WLE group (P＜0.05). The polyp detection rate in IEE group was higher than that in WLE group (45.6% vs. 38.7%, χ2=7.273, P=0.007). The polyps in the two groups were mainly adenomas, but the adenomas detection rate in IEE group was lower than that of WLE group (42.6% vs. 51.8%, χ2=8.242, P=0.004), the other pathological types of polyps which include inflammatory polyps, serrated polyps, hyperplastic polyps and cancer were not statistically different between the two groups (all P＞0.05). The average number of positive adenomas detected in IEE group was slightly higher than that in WLE group ［1(1~6) vs. 1(1~5), Z=-1.966, P=0.049］, and there was no difference in the average number of adenomas detected ［0(0~6) vs. 0(0~5), Z=-1.070, P=0.285］. Subgroup analysis showed that the overall ADR difference between NBI group and WLE group was not statistically significant (24.0% vs. 22.1%, χ2=0.710, P=0.399); the overall ADR of LCI group was higher than that of WLE group (32.9% vs. 22.1%, χ2=4.126, P=0.042). Conclusion    The initial results suggest that the adenoma detection rate in the IEE (NBI based) is not better than that of the WLE, the polyp detection rate is higher than that of the WLE, and the detection ability of non-adenomatous polyps is similar to that of WLE. It needs to be confirmed by further sample size analysis.

Key words: image-enhanced endoscopy colonoscopy, randomized controlled study, colorectal polyps, adenoma detection rate

摘要： 目的    比较评估图像增强内镜（IEE）模式与传统白光模式行结肠镜检查的腺瘤检出率（ADR）。方法  选择2019年10月至2020年6月复旦大学附属中山医院及附属徐汇医院（1253例）、复旦大学附属中山医院厦门医院（62例）、荣成市中医院（207例）4家中心共1522例病人。采用中心分层随机化方法随机分为两组并筛选有效病例，增强组采用白光模式进镜、增强模式退镜（最终纳入有效病例748例），白光组进镜、退镜均采用白光模式（最终纳入有效病例727例）。比较分析两组ADR、息肉检出率、腺瘤平均检出数目及检出腺瘤大小、位置、数量、形态、退镜时间等指标。进一步根据不同增强模式将增强组分为NBI组和LCI组进行亚组分析。结果    增强组与白光组的总体ADR差异无统计学意义（24.9% vs. 22.1%，χ2=1.517，P=0.218），但在＜50岁的病人中，尤其是以筛查为目的者，增强组ADR高于白光组（P＜0.05）。增强组息肉检出率高于白光组（45.6% vs. 38.7%，χ2=7.273，P=0.007），两组息肉检出均以腺瘤为主，但增强组腺瘤的检查率低于白光组（42.6% vs. 51.8%，χ2=8.242，P=0.004），其余病理学类型的息肉（炎症性息肉、锯齿状息肉、增生性息肉、癌）两组间差异无统计学意义（P均＞0.05）。增强组阳性腺瘤平均检出数略高于白光组［1（1~6）枚 vs. 1（1~5）枚，Z=-1.966，P=0.049］，平均腺瘤检出数差异无统计学意义［0（0~6）枚 vs. 0（0~5）枚，Z=-1.070，P=0.285］。亚组分析显示，NBI组与白光组总体ADR差异无统计学意义（24.0% vs. 22.1%，χ2=0.710，P=0.399）；LCI组总体ADR高于白光组（32.9% vs. 22.1%，χ2=4.126，P=0.042）。结论    初期结果提示，IEE模式（NBI为主）的总体ADR并未优于白光模式，息肉检出率高于白光模式，非腺瘤检出能力与白光模式相仿。有待进一步增加样本量分析证实。

关键词: 图像增强内镜, 随机对照研究, 结直肠息肉, 腺瘤检出率