Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of Sao Paulo Medical School, Av. Dr. Enéas de Carvalho Aguiar, 255. Cerqueira César, São Paulo, 05403-000, Brazil.
Surg Endosc. 2020 Jan;34(1):317-324. doi: 10.1007/s00464-019-06769-z. Epub 2019 Mar 29.
Despite advances in pharmacological and endoscopic management of non-variceal upper gastrointestinal bleeding (NVUGIB), mortality is still relevant. TC-325 (Hemospray-Cook Medical) is a mineral powder with adsorptive properties, designed for endoscopic hemostasis. There are still no comparative trials studying this new hemostatic modality. The objective of this research was to compare the use of TC-325 (associated with epinephrine injection) with the combined technique of endoscopic clipping and epinephrine injection for the treatment of patients with NVUGIB.
We conducted a pilot randomized controlled trial with patients that presented NVUGIB with an actively bleeding lesion at the endoscopic evaluation. Patients were randomized either to the Hemospray or Hemoclip group. The randomization list was generated by a computer program and remained unknown throughout the entire trial. All patients underwent second-look endoscopy.
Thirty-nine patients were enrolled. Peptic ulcer was the most frequent etiology. Primary hemostasis was achieved in all Hemospray cases and in 90% of Hemoclip group (p = 0.487). Five patients in Hemospray group underwent an additional hemostatic procedure during second-look endoscopy, while no patient in the Hemoclip group needed it (p = 0.04). Rebleeding, emergency surgery and mortality rates were similar in both groups. No toxicity, allergy events, or gastrointestinal obstruction signs were observed in Hemospray group.
TC-325 presents similar hemostatic results when compared with conventional dual therapy for patients with NVUGIB. Hemospray's excellent primary hemostasis rate certifies it as a valuable tool in arduous situations of severe bleeding or difficult location site.
尽管在非静脉曲张性上消化道出血（NVUGIB）的药物治疗和内镜治疗方面取得了进展，但死亡率仍然很高。TC-325（库克医疗公司的 Hemospray）是一种具有吸附性能的矿物质粉末，旨在进行内镜止血。目前尚无比较研究这种新止血方式的临床试验。本研究旨在比较 TC-325（联合肾上腺素注射）与内镜夹闭联合肾上腺素注射治疗 NVUGIB 患者的效果。
我们进行了一项前瞻性随机对照试验，纳入了内镜评估时存在活动性出血病变的 NVUGIB 患者。患者被随机分为 Hemospray 组或 Hemoclip 组。随机分组名单由计算机程序生成，整个试验过程中均处于保密状态。所有患者均接受了第二次内镜检查。
共纳入 39 例患者。消化性溃疡是最常见的病因。所有 Hemospray 组患者均实现了初次止血，而 Hemoclip 组中有 90%的患者实现了初次止血（p=0.487）。Hemospray 组中有 5 例患者在第二次内镜检查时需要进行额外的止血治疗，而 Hemoclip 组中无一例患者需要（p=0.04）。两组患者的再出血、紧急手术和死亡率相似。Hemospray 组未观察到任何毒性、过敏事件或胃肠道梗阻迹象。
与 NVUGIB 患者的常规双联治疗相比，TC-325 具有相似的止血效果。Hemospray 出色的初次止血率证明它是在严重出血或难以定位的困难情况下的一种有价值的工具。
