Yamaguchi Daisuke, Tominaga Naoyuki, Mori Genki, Yasuda Takeshi, Yukimoto Takahiro, Minoda Yosuke, Miyahara Koichi, Ohtsu Kensei, Ito Yoichiro, Yamanouchi Kohei, Gondo Kasumi, Nomura Tadahiro, Tanaka Yuichiro, Tomonaga Michito, Esaki Mitsuru, Shimamura Takuya, Takeuchi Yuki, Esaki Motohiro
Department of Gastroenterology, National Hospital Organization Ureshino Medical Center, Ureshino, Japan; Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
Department of Gastroenterology, Saga-Ken Medical Centre Koseikan, Saga, Japan.
Gastrointest Endosc. 2025 Apr;101(4):894-902. doi: 10.1016/j.gie.2024.11.006. Epub 2024 Nov 8.
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).
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.
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).
PuraStat can be easily added to conventional hemostatic methods for CDB, which could lower the risk of recurrent bleeding. (Clinical trial registration number: UMIN000053065.).
PuraStat（3-D Matrix，日本东京）是一种采用自组装肽技术的吸收性局部止血剂。在这项多中心试点研究中，我们评估了使用PuraStat进行内镜止血治疗结肠憩室出血（CDB）患者的疗效和安全性。
本研究纳入了患有近期出血迹象（SRH）的CDB患者，他们接受了PuraStat单一疗法或PuraStat与内镜下套扎术（EBL）或夹子夹闭术联合治疗（A组）。评估了治疗结果和不良事件，并与之前一组未使用PuraStat进行内镜止血治疗的患有SRH的CDB患者（B组）进行比较。随后研究了与复发出血减少相关的因素。
25例CDB患者使用了PuraStat。患者平均年龄为70.8岁，13例（52.0%）为男性，最常见的出血部位是升结肠（15例患者[60.0%]）。内镜止血成功率为100%（25/25）；2例患者接受PuraStat单一疗法治疗，23例接受联合治疗（EBL，13例患者；夹子夹闭术，10例患者）。A组和B组的成功率相当（100%对96.4%，P = 1.000）。A组30天内的复发出血率显著低于B组（4.0%对20.9%，P = .047）。多变量分析显示，添加PuraStat与复发出血风险降低相关（比值比，.11；95%置信区间，.01-.95；P = .045）。
PuraStat可轻松添加到CDB的传统止血方法中，这可能降低复发出血的风险。（临床试验注册号：UMIN000053065。）
