Iwai Naoto, Dohi Osamu, Kotachi Takahiro, Tsuda Momoko, Yagi Nobuaki, Ono Shoko, Seya Mayuko, Teshima Hajime, Kubo Kimitoshi, Nakahata Yuki, Obora Akihiro, Oka Shiro, Tanaka Shinji, Itoh Yoshito, Kato Mototsugu
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kawaramachi Hirokoji Kamigyo-ku, Kyoto, 602-8566, Japan.
Department of Gastroenterology, Hiroshima University Hospital, Hiroshima, Japan.
Dig Dis Sci. 2025 Feb;70(2):794-801. doi: 10.1007/s10620-024-08785-z. Epub 2024 Dec 13.
Early detection of gastric cancer can play a key role in improving prognosis. Recently, light-emitting diodes (LED) have been developed as novel endoscopic systems. However, the differences in the visibility of gastric neoplastic lesions between LED and laser endoscopy remains unclear. We conducted a prospective multicenter trial to evaluate the non-inferiority of LED endoscopy in the visibility of gastric neoplastic lesions undergoing endoscopic submucosal dissection (ESD) in comparison to laser endoscopy.
A multicenter, prospective, cross-sectional study was conducted in patients undergoing ESD for gastric neoplastic lesions at five hospitals throughout Japan. Seventy patients with 74 lesions were included in this study. The primary endpoint was the non-inferiority of the difference in the individual scores of linked color imaging (LCI) and white-light imaging (WLI) for LED and laser endoscopy for gastric neoplastic lesions.
The mean individual score was 2.66 ± 1.02, 3.17 ± 0.83, 2.75 ± 1.05, and 3.21 ± 0.84 in LED-WLI, LED-LCI, laser-WLI, and laser-LCI, respectively. The difference in individual scores of LCI and WLI was 0.51 ± 0.77 and 0.46 ± 0.80 in LED and laser endoscopy, respectively. The mean difference between LED and laser endoscopy was 0.04 (95% confidence interval [CI]: - 0.05 to 0.13, P < 0.001).
This study revealed the non-inferiority of the differences in individual scores between LCI and WLI in the comparison of LED and laser endoscopy for gastric neoplastic lesions.
早期发现胃癌对改善预后起着关键作用。近年来,发光二极管(LED)已被开发为新型内镜系统。然而,LED内镜与激光内镜在胃肿瘤性病变可视性方面的差异仍不明确。我们进行了一项前瞻性多中心试验,以评估LED内镜在胃肿瘤性病变内镜黏膜下剥离术(ESD)中与激光内镜相比在可视性方面的非劣效性。
在日本全国五家医院对接受胃肿瘤性病变ESD的患者进行了一项多中心、前瞻性、横断面研究。本研究纳入了70例患者的74个病变。主要终点是LED和激光内镜对胃肿瘤性病变的联合彩色成像(LCI)和白光成像(WLI)个体评分差异的非劣效性。
LED-WLI、LED-LCI、激光-WLI和激光-LCI的个体平均评分分别为2.66±1.02、3.17±0.83、2.75±1.05和3.21±0.84。LED和激光内镜中LCI和WLI的个体评分差异分别为0.51±0.77和0.46±0.80。LED与激光内镜的平均差异为0.04(95%置信区间[CI]:-0.05至0.13,P<0.001)。
本研究揭示了在胃肿瘤性病变的LED和激光内镜比较中,LCI和WLI个体评分差异的非劣效性。