Haddara Sami, Jacques Jeremie, Lecleire Stéphane, Branche Julien, Leblanc Sarah, Le Baleur Yann, Privat Jocelyn, Heyries Laurent, Bichard Philippe, Granval Philippe, Chaput Ulriikka, Koch Stephane, Levy Jonathan, Godart Bruno, Charachon Antoine, Bourgaux Jean-François, Metivier-Cesbron Elodie, Chabrun Edouard, Quentin Vincent, Perrot Bastien, Vanbiervliet Geoffroy, Coron Emmanuel
Institut des Maladies de l'Appareil Digestif, University Hospital, Nantes, France.
Service d'Hépato-gastro-entérologie, CHU Dupuytren, Limoges, France.
Endoscopy. 2016 Dec;48(12):1084-1095. doi: 10.1055/s-0042-116148. Epub 2016 Oct 19.
The hemostatic powder TC-325 (Hemospray; Cook Medical, Winston-Salem, North Carolina, USA) has shown promising results in the treatment of upper gastrointestinal bleeding (UGIB) in expert centers in pilot studies. The aim of this study was to evaluate the feasibility and efficacy of TC-325 in a large prospective registry of use in routine practice. The data of all patients treated with TC-325 were prospectively collected through a national registry. Outcomes were the immediate feasibility and efficacy of TC-325 application, as well as the rates of rebleeding at Day 8 and Day 30. Multivariate analysis was performed to determine predictive factors of rebleeding. A total of 202 patients were enrolled and 64 endoscopists participated from 20 centers. TC-325 was used as salvage therapy in 108 patients (53.5 %). The etiology of bleeding was an ulcer in 75 patients (37.1 %), tumor in 61 (30.2 %), postendoscopic therapy in 35 (17.3 %), or other in 31 (15.3 %). Application of the hemostatic powder was found to be very easy or easy in 31.7 % and 55.4 %, respectively. The immediate efficacy rate was 96.5 %. Recurrence of UGIB was noted at Day 8 and Day 30 in 26.7 % and 33.5 %, respectively. Predictive factors of recurrence at Day 8 were melena at initial presentation and use of TC-325 as salvage therapy. These multicenter data confirmed the high rate of immediate hemostasis, excellent feasibility, and good safety profile of TC-325, which could become the treatment of choice in bleeding tumors or postendoscopic bleeding but not in bleeding ulcers where randomized studies are needed.
ClinicalTrials.gov (NCT02595853).
止血粉TC-325（Hemospray；美国北卡罗来纳州温斯顿-塞勒姆市库克医疗公司）在前期研究中已在专业中心的上消化道出血（UGIB）治疗中显示出有前景的结果。本研究的目的是在一个大型前瞻性常规应用登记研究中评估TC-325的可行性和疗效。通过一个全国性登记系统前瞻性收集了所有接受TC-325治疗患者的数据。结局指标为TC-325应用的即刻可行性和疗效，以及第8天和第30天的再出血率。进行多变量分析以确定再出血的预测因素。共有202例患者入组，来自20个中心的64位内镜医师参与。108例患者（53.5%）将TC-325用作挽救治疗。出血病因包括溃疡75例（37.1%）、肿瘤61例（30.2%）、内镜治疗后35例（17.3%）或其他31例（15.3%）。分别有31.7%和55.4%的人认为止血粉的应用非常容易或容易。即刻有效率为96.5%。分别有26.7%和33.5%的患者在第8天和第30天出现UGIB复发。第8天复发的预测因素为初次就诊时出现黑便以及将TC-325用作挽救治疗。这些多中心数据证实了TC-325的高即刻止血率、出色的可行性和良好的安全性，它可能成为出血性肿瘤或内镜后出血的首选治疗方法，但在出血性溃疡方面并非如此，对此需要进行随机研究。
ClinicalTrials.gov（NCT02595853）
