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

Abstract

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

Methods: 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.

Results: 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).

Conclusions: 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.