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

BACKGROUND AND AIMS: PuraStat (3-D Matrix, Tokyo, Japan) is an absorbent localized hemostatic agent that uses 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 recurrent bleeding were subsequently investigated.

RESULTS

PuraStat was used in 25 patients with CDB. The mean patient age was 70.8 years, 13 (52.0%) were men, and the most frequent bleeding sites were in the ascending colon (15 patients [60.0%]). 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 recurrent bleeding within 30 days was significantly lower in group A than in group B (4.0% vs 20.9%, P = .047). Multivariate analyses revealed that the addition of PuraStat was associated with the reduced risk of recurrent bleeding (odds ratio, .11; 95% confidence interval, .01-.95; P = .045).

CONCLUSIONS

PuraStat can be easily added to conventional hemostatic methods for CDB, which could lower the risk of recurrent bleeding. (Clinical trial registration number: UMIN000053065.).