Maselli Roberta, Da Rio Leonardo, Manno Mauro, Soriani Paola, Andrisani Gianluca, Di Matteo Francesco Maria, Fabbri Carlo, Sbrancia Monica, Binda Cecilia, Panarese Alba, D'Abramo Fulvio, Staiano Teresa, Rizza Stefano, Cannizzaro Renato, Maiero Stefania, Stigliano Vittoria, de Nucci Germana, Manes Gianpiero, Sacco Marco, Facciorusso Antonio, Hassan Cesare, Repici Alessandro
Endoscopy Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Endosc Int Open. 2024 Oct 28;12(10):E1220-E1229. doi: 10.1055/a-2406-7492. eCollection 2024 Oct.
Topical hemostatic agents emerged as a new treatment modality for gastrointestinal bleeding. The aim of this study was to assess the safety and efficacy of PuraStat for control of active bleeding and for prevention of bleeding after different operative endoscopy procedures. A national, multicenter, observational registry was established to collect data from ten Italian centers from June 2021 to February 2023. Demographics, type of application (active gastrointestinal bleeding or prevention after endoscopic procedures, site, amount of gel used, completeness of coverage of the treated area), outcomes (rates of intraprocedural hemostasis and bleeding events during 30-day follow-up), and adverse events (AEs) were prospectively analyzed. Four hundred and one patients were treated for active gastrointestinal bleeding or as a preventive measure after different types of operative endoscopy procedures. Ninety-one treatments for active bleeding and 310 preventive applications were included. In 174 of 401 cases (43.4%), PuraStat was the primary treatment modality. Complete coverage was possible in 330 of 401 (82.3%) with difficulty in application in seven of 401 cases (1.7%). Hemostasis of active bleedings was achieved in 90 of 91 patients (98.9%). In 30-day follow-up 3.9% patients in whom PuraStat was used for prophylaxis had a bleeding event compared with 7.7% after hemostasis. No AEs related to the use of PuraStat were reported. PuraStat is a safe and effective hemostat both for bleeding control and for bleeding prevention after different operative endoscopy procedures. Our results suggest that the possible applications for the use of PuraStat may be wider compared with current indications.
局部止血剂成为胃肠道出血的一种新治疗方式。本研究的目的是评估PuraStat在控制活动性出血以及预防不同手术内镜操作后出血方面的安全性和有效性。建立了一个全国性、多中心的观察性登记系统，以收集2021年6月至2023年2月期间来自意大利十个中心的数据。对人口统计学、应用类型（活动性胃肠道出血或内镜操作后的预防、部位、使用的凝胶量、治疗区域的覆盖完整性）、结果（术中止血率和30天随访期间的出血事件）以及不良事件进行前瞻性分析。401例患者接受了治疗，用于治疗活动性胃肠道出血或作为不同类型手术内镜操作后的预防措施。其中包括91例活动性出血治疗和310例预防性应用。在401例病例中的174例（43.4%）中，PuraStat是主要治疗方式。401例中的330例（82.3%）能够实现完全覆盖，401例中有7例（1.7%）应用困难。91例活动性出血患者中有90例（98.9%）实现了止血。在30天随访中，使用PuraStat进行预防的患者中有3.9%发生出血事件，而止血后为7.7%。未报告与使用PuraStat相关的不良事件。PuraStat在不同手术内镜操作后控制出血和预防出血方面都是一种安全有效的止血剂。我们的结果表明，与目前的适应症相比，PuraStat的可能应用范围可能更广。
