BACKGROUND: Endoscopic mucosal dissection has become the standard treatment for early gastric cancer. However, post-endoscopic submucosal dissection (ESD) ulcer occurs in 4.4% of patients. This study hypothesized whether applying PuraStat, a novel hemostatic peptide solution, prevents post-ESD bleeding.
AIM: To investigate the preventive potential of PuraStat, a hemostatic formulation, against bleeding in post-ESD gastric ulcers.
METHODS: Between May 2022 and March 2023, 101 patients (Group P) underwent ESD for gastric diseases at our hospital and received PuraStat (2 mL) for post-ESD ulcers. We retrospectively compared this group with a control group (Group C) comprising 297 patients who underwent ESD for gastric diseases at our hospital between April 2017 and March 2021. values < 0.05 on two-sided tests indicated significance.
RESULTS: Post-ESD bleeding occurred in 6 (5.9%) (95%CI: 2.8-12.4) and 20 (6.7%) (95%CI: 4.4-10.2) patients in Groups P and C, respectively, with no significant between-group difference. The relative risk was 1.01 (95%CI: 0.95-1.07). The lesser curvature or anterior wall was the bleeding site in all 6 patients who experienced postoperative bleeding in Group P. In multivariate analysis, the odds ratios for resection diameter ≥ 50 mm and oral anticoagulant use were 6.63 (95%CI: 2.52-14.47; = 0.0001) and 4.04 (1.26-0.69; = 0.0164), respectively. The adjusted odds ratio of post-ESD bleeding and PuraStat was 1.28 (95%CI: 0.28-2.15).
CONCLUSION: PuraStat application is not associated with post-ESD bleeding. However, the study suggests that gravitational forces may affect the effectiveness of applied PuraStat.
