Efficacy and safety of endoscopic hemostasis with a self-assembling peptide solution in patients with colonic diverticular bleeding: A multicenter pilot study.

Abstract

Background and aims: PuraStat (3-D Matrix, Tokyo, Japan) is an absorbent localized hemostatic agent that utilizes self-assembling peptide technology. In this multicenter pilot study, we evaluated the efficacy and safety of endoscopic hemostasis using PuraStat in patients with colonic diverticular bleeding (CDB).

Methods: This study involved patients who had CDB with stigmata of recent hemorrhage (SRH) and underwent endoscopic hemostasis with PuraStat monotherapy or combination therapy comprising PuraStat with endoscopic band ligation (EBL) or clipping (Group A). Treatment outcomes and adverse events were assessed and compared with those of a previous cohort who underwent endoscopic hemostasis without PuraStat for CDB with SRH (Group B). Factors associated with the reduction of rebleeding were subsequently investigated.

Results: PuraStat was used in 25 patients with CDB. Their mean age was 70.8 years, 13 (52.0%) were male, and the most frequent bleeding sites were in the ascending colon [15 (60.0%) patients]. The success rate of endoscopic hemostasis was 100% (25/25); 2 patients were treated with PuraStat monotherapy and 23 with combination therapy (EBL, 13 patients; clipping, 10 patients). The success rates were comparable between Groups A and B (100% vs. 96.4%, P=1.000). The rate of rebleeding within 30 days was significantly lower in Group A than B (4.0% vs. 20.9%, P=0.047). Multivariate analyses revealed that the addition of Purastat was associated with the reduced risk of rebleeding (odds ratio 0.11, 95% confidence interval 0.01-0.95; P=0.045).

Conclusions: PuraStat can be easily added to the conventional hemostatic methods for CDB, that could lower the risk of rebleeding.