A Randomized Controlled Trial to Evaluate the Effect of Fibrin Glue on Bleeding after Gastric Endoscopic Submucosal...

This study aimed to evaluate the effectiveness of fibrin glue application in reducing bleeding after endoscopic submucosal dissection (ESD) in the general patient population.

This randomized controlled trial enrolled 262 patients who underwent ESD for gastric neoplasms. The participants were randomized into the fibrin glue group (n=133) or the control group (n=129). The primary outcome was the post-ESD bleeding rate, which was compared between the two groups. Additionally, exploratory subgroup analyses were conducted for high-risk patients, which included patients taking antithrombotic agents (ATAs) and patients with resected specimens measuring 4 cm or greater.

In the modified intention-to-treat population (n=252), the overall bleeding rate occurred in 10.7% of cases, including 10.3% of patients in the fibrin glue group and 11.1% of patients in the control group (p=0.839). In the per-protocol population (n=248), the bleeding rates were 10.3% in the fibrin glue group and 10.7% in the control group (p=1.000). Among ATA users, the overall bleeding rate was 18.0%, including 9.5% of patients in the fibrin glue group and 24.1% of patients in the control group (p=0.271). Among ATA users with specimens measuring 4 cm or larger, the overall bleeding rate was 18.4%, including 12.5% of patients in the fibrin glue group and 22.7% of patients in the control group (p=0.675).

Routine application of fibrin glue after ESD did not significantly reduce postoperative bleeding. Although the results of subgroup analyses suggested a potential reduction in early bleeding among high-risk patients, these findings warrant further investigation.