Clinical usefulness of red dichromatic imaging in hemostatic treatment 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: 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. RESULTS: 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. CONCLUSIONS: 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.

The acetic acid + indigocarmine method in the delineation of gastric cancer.

BACKGROUND AND AIM: For the purpose of precise preoperative diagnosis that ensures complete endoscopic resection, it is important to accurately determine the lateral spread of gastric cancer lesions. The acetic acid + indigocarmine (AI) method used by us has been found to meet this need. This paper reports its usefulness in the determination of lateral spread of gastric cancer before endoscopic submucosal dissection (ESD). METHODS: The present study was conducted in 114 patients who were operated on for an early-stage gastric cancer, after determining the lateral spread of cancerous lesions by the AI method, between September 2005 and December 2006. The negative lateral stump reaction rate obtained in ESD was conducted in areas delineated by the AI method. The borderline clarification rate obtained by the AI method and the indigocarmine (I) method were compared between the lesions with and without clear borders under observation with the naked eye. RESULTS: The lateral stump after ESD conducted using the AI method was histologically negative in 111 of the 114 patients (97%). The lesion spread was clarified by the AI method in 103 patients (90%): 55 (95%) and 48 (86%) patients with and without clear macroscopic lesion borders, respectively. Compared to the I method, the AI method clarified the lesion spread in a significantly higher percentage of patients with macroscopically unclear lesion borders (P = 0.015). CONCLUSION: The present study stresses that the AI method should be used to conduct ESD more safely and accurately in patients with well or moderately differentiated adenocarcinoma.