Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan.
Department of Gastroenterology and Hepatology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
Dig Endosc. 2022 Jan;34(2):379-390. doi: 10.1111/den.14191. Epub 2021 Dec 20.
To verify the efficacy and safety of red dichromatic imaging (RDI) in hemostatic procedures during endoscopic submucosal dissection (ESD).
This is a multicenter randomized controlled trial of 404 patients who underwent ESD of the esophagus, stomach, colorectum. Patients who received hemostatic treatments by RDI during ESD were defined as the RDI group (n = 204), and those who received hemostatic treatments by white light imaging (WLI) were defined as the WLI group (n = 200). The primary endpoint was a shortening of the hemostasis time. The secondary endpoints were a reduction of the psychological stress experienced by the endoscopist during the hemostatic treatment, a shortened treatment time, and a non-inferior perforation rate, in RDI versus WLI.
The mean hemostasis time in RDI (n = 860) was not significantly shorter than that in WLI (n = 1049) (62.3 ± 108.1 vs. 56.2 ± 74.6 s; P = 0.921). The median hemostasis time was significantly longer in RDI than in WLI (36.0 [18.0-71.0] vs. 28.0 [14.0-66.0] s; P = 0.001) in a sensitivity analysis. The psychological stress was significantly lower in RDI than in WLI (1.71 ± 0.935 vs. 2.03 ± 1.038; P < 0.001). There was no significant difference in the ESD treatment time between RDI (n = 161) and WLI (n = 168) (58.0 [35.0-86.0] vs. 60.0 [38.0-88.5] min; P = 0.855). Four perforations were observed, but none of them took place during the hemostatic treatment.
Hemostatic treatment using RDI does not shorten the hemostasis time. RDI, however, is safe to use for hemostatic procedures and reduces the psychological stress experienced by endoscopists when they perform hemostatic treatment during ESD. UMIN000025134.
验证红色双色调成像（RDI）在内镜黏膜下剥离术（ESD）止血过程中的疗效和安全性。
这是一项多中心、随机对照试验，纳入了 404 例接受食管、胃、结直肠 ESD 的患者。在 ESD 中接受 RDI 止血治疗的患者被定义为 RDI 组（n=204），接受白光成像（WLI）止血治疗的患者被定义为 WLI 组（n=200）。主要终点是缩短止血时间。次要终点是比较 RDI 与 WLI 时，内镜医师在止血治疗过程中所经历的心理压力降低、治疗时间缩短和非劣效穿孔率。
RDI 组（n=860）的平均止血时间与 WLI 组（n=1049）相比无显著缩短（62.3±108.1 vs. 56.2±74.6 s；P=0.921）。在敏感性分析中，RDI 组的中位止血时间明显长于 WLI 组（36.0[18.0-71.0] vs. 28.0[14.0-66.0] s；P=0.001）。RDI 组的心理压力明显低于 WLI 组（1.71±0.935 vs. 2.03±1.038；P<0.001）。RDI 组（n=161）和 WLI 组（n=168）的 ESD 治疗时间无显著差异（58.0[35.0-86.0] vs. 60.0[38.0-88.5] min；P=0.855）。共观察到 4 例穿孔，但均未发生在止血治疗过程中。
使用 RDI 进行止血治疗并不能缩短止血时间。然而，RDI 用于止血操作是安全的，可降低内镜医师在 ESD 中进行止血治疗时所经历的心理压力。UMIN000025134。
