Effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm : A prospective randomized controlled study

Baseline characteristics and treatment outcomes This trial was performed between July 1, 2020, and June 22, 2022. In total, 254 patients were randomized, and 247 patients were included in the modified intention-to-treat population (125 patients in the fibrin glue group and 122 patients in the control group) (Figure 3). Participants’ baseline characteristics are summarized in Table 1. The mean age was 67.7 years (range, 28–84 years). This trial included 185 (74.9%) men and 62 (25.1%) women. Thirty-six percentage (90/247) of patients took antithrombotic drugs, and 3.6% (9/247) were on dual antiplatelet therapy. Antithrombotics were continued in 7.3% (18/247) of enrolled patients. The 2 groups showed no significant differences in age, sex, comorbidities, antithrombotic medication, laboratory results, or endoscopic findings. Table 2 summarizes the histopathologic characteristics and procedural characteristics of the 2 groups. No significant betweengroup differences were found in histopathology, size of ESD specimen, tumor depth, procedure time, endoscopic clipping for hemostasis, preventive coagulation time, or rates of complete/curative resection. The mean time of applying fibrin glue to the iatrogenic ulcer was 1.5 minutes.