Toyoshima Naoya, Sakamoto Taku, Shinmura Kensuke, Hotta Kinichi, Misawa Masashi, Tamai Naoto, Uraoka Toshio, Matsuda Takahisa, Shibata Taro, Mizuguchi Yasuhiko, Takamaru Hiroyuki, Nakamura Keiko, Kakugawa Yasuo, Shiroyama Mamiko, Kawagoe Ryosuke, Tsuchiya Kiichiro, Ikematsu Hiroaki, Inaba Atsushi, Minakata Nobuhisa, Imai Kenichiro, Takada Kazunori, Ito Sayo, Wakamura Kunihiko, Kudo Shin-Ei, Sumiyama Kazuki, Ito Mamoru, Tomaru Shota, Fujimoto Ai, Saito Yutaka
Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
Department of Gastroenterology, University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan.
Gastroenterology. 2025 Aug;169(2):337-345.e2. doi: 10.1053/j.gastro.2025.03.007. Epub 2025 Mar 18.
BACKGROUND & AIMS: Colonoscopy is the gold standard for detecting and resecting adenomas and early-stage cancers to reduce colorectal cancer (CRC) incidence and mortality rates. This study aimed to confirm the superiority of texture and color enhancement imaging (TXI) over white light imaging (WLI) in detecting colorectal lesions.
This randomized controlled trial was conducted at 8 Japanese institutions between March 2023 and October 2023. Participants aged 40 to 80 years old scheduled for CRC screening and nonscreening purposes, such as postpolypectomy surveillance, positive fecal occult blood test results, and abdominal symptoms, were included. We used only the latest model colonoscopes and performed observations in each arm of the TXI mode 1 and WLI. The primary end point was the mean number of adenomas detected per procedure. Secondary end points included the adenoma detection rate, polyp detection rate, flat polyp detection rate, and adverse events.
A total of 956 patients were enrolled and randomized. After patients who did not meet the eligibility criteria were excluded, 451 and 445 patients were included in the TXI and WLI arms, respectively. The mean number of adenomas detected per procedure was 1.4 and 1.5 and the adenoma detection rate was 57.2% and 56.0% in TXI and WLI, respectively, and there were no statistically significant differences between 2 arms. The polyp detection rate and flat polyp detection rate were significantly higher in TXI than in WLI, which were 82.5% vs 74.4% (P = .003), and 76.5% vs 70.3% (P = .036), respectively.
This study did not demonstrate the superiority of TXI over WLI in detecting neoplastic lesions. However, TXI may be effective in detecting flat polyps. (Clinical trial registration: jRCT1032230089.).
结肠镜检查是检测和切除腺瘤及早期癌症以降低结直肠癌(CRC)发病率和死亡率的金标准。本研究旨在证实纹理和颜色增强成像(TXI)在检测结直肠病变方面优于白光成像(WLI)。
本随机对照试验于2023年3月至2023年10月在8家日本机构进行。纳入年龄在40至80岁之间、计划进行CRC筛查及非筛查目的(如息肉切除术后监测、粪便潜血试验结果阳性和腹部症状)的参与者。我们仅使用最新款结肠镜,并在TXI模式1和WLI的每个臂中进行观察。主要终点是每次检查检测到的腺瘤平均数量。次要终点包括腺瘤检出率、息肉检出率、扁平息肉检出率和不良事件。
共纳入956例患者并进行随机分组。排除不符合纳入标准的患者后,TXI组和WLI组分别纳入451例和445例患者。TXI组和WLI组每次检查检测到的腺瘤平均数量分别为1.4个和1.5个,腺瘤检出率分别为57.2%和56.0%,两组之间无统计学显著差异。TXI组的息肉检出率和扁平息肉检出率显著高于WLI组,分别为82.5%对74.4%(P = .003)和76.5%对70.3%(P = .036)。
本研究未证明TXI在检测肿瘤性病变方面优于WLI。然而,TXI在检测扁平息肉方面可能有效。(临床试验注册号:jRCT1032230089。)