Usefulness of Red Dichromatic Imaging in hemostatic procedure during endoscopic submucosal dissection: first report from a multicenter, open-label, randomized controlled trial.

Objectives: To verify the efficacy and safety of Red Dichromatic Imaging (RDI) in hemostatic procedures during endoscopic submucosal dissection (ESD).
Methods: 404 patients who underwent esophageal, gastric, and colorectal ESD were allocated randomly in two group. When bleeding occurred, hemostatic procedure was performed using RDI (RDI group, n=204) or white light imaging (WLI group, n=200). The primary endpoint was a shortening of the time required to achieve hemostasis (hemostasis time). The secondary endpoints were a reduction of the psychological stress experienced by the endoscopist during the hemostatic procedure, a shortened treatment time, and a non-inferior perforation rate, in RDI versus WLI group.
Results: Hemostasis time did not significantly differ between RDI (n=860) and WLI group (n=1049) (62.3±108.1 versus 56.2±74.6 seconds; p=0.157). The psychological stress score was significantly lower in RDI than in WLI group (1.71±0.935 versus 2.03±1.038; p<0.001). There was no significant difference in the treatment time between RDI (n=161) and WLI group (n=168) (68.5±46.1 versus 69.9±47.3 minutes; p=0.607). Four perforations, two in each group, were observed, but none of them occurred during the hemostatic treatment.
Conclusions: Hemostatic procedure 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 during hemostatic procedure.