Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Gastrointest Endosc. 2012 Jan;75(1):3-10. doi: 10.1016/j.gie.2011.11.003.
Recently, endoscopic clip application devices have undergone redesign and improvements to optimize their clinical use and effectiveness. Initially designed for the treatment of bleeding nonvariceal lesions, these devices are also increasingly used for the closure of perforations, fistulas, and anastomotic leaks. Several clinical studies, both randomized and nonrandomized, have used endoscopic hemoclips for hemostasis. However, no comparative studies have yet been reported in the literature comparing the latest endoscopic clip devices for usability and effectiveness for hemostasis of acute upper GI hemorrhage.
We aimed to compare the usability and efficacy of 3 different types of endoscopic clip application devices in an established experimental setting by using a porcine ex-vivo simulator of upper GI hemorrhage.
Randomized, controlled, ex-vivo study.
Academic medical center.
Spurting vessels were created within ex-vivo porcine stomachs as published in prior studies. The vessels were attached to a pressure transducer to record the pressure of the circulating blood replacement. Before the initiation of bleeding, each vessel was randomized to 1 of 3 endoscopic clipping devices: 2 different commonly used hemoclips deployed through the working channel and 1 novel clip deployed via an over-the-scope applications device. Two investigators treated 45 bleeding sites (15 bleeding sites for each device at various randomized locations in the stomach: fundus, body, and antrum).
Usability was measured via the endpoints of procedure time and quantity of clips required to achieve hemostasis. Efficacy was measured via the endpoint of pressure increase (Δp) from baseline to after treatment.
All of the 45 hemostasis treatments were carried out successfully. The mean procedure times were significantly different among the hemoclips, with the clip deployed in an over-the-scope fashion requiring significantly less time to attain hemostasis compared with the other 2 clips. For number of clips needed to attain hemostasis, the clip deployed in an over-the-scope fashion was significantly superior to the others. There were also significant differences among the changes in pressure (Δp ± SD) among the different hemoclips tested.
Ex-vivo study.
In this prospective, randomized ex-vivo study, we observed significant differences in the usability (time to achieve hemostasis and number of clips required) and the efficacy (change in pressure achieved by the hemoclips) among the 3 clips. The clip applied in the over-the-scope fashion was superior to the other 2 tested clips with regard to time to achieve hemostasis and number of clips required.
最近，内镜夹应用设备经过重新设计和改进，以优化其临床使用和效果。这些设备最初设计用于治疗非静脉曲张性出血病变，但也越来越多地用于穿孔、瘘管和吻合口漏的闭合。一些临床研究，包括随机和非随机研究，已经使用内镜夹进行止血。然而，文献中尚未报道比较最新的内镜夹设备在急性上消化道出血止血方面的可用性和有效性的对照研究。
我们旨在使用猪上消化道出血的体外模型，比较 3 种不同类型的内镜夹应用设备在既定实验环境中的可用性和疗效。
随机对照的体外研究。
学术医疗中心。
如先前研究中所述，在猪胃的体外模型中创建喷血血管。将血管连接到压力传感器上，以记录循环血液替代物的压力。在开始出血之前，每个血管随机分配到 3 种内镜夹中的 1 种：通过工作通道部署的 2 种常用止血夹和通过过镜应用装置部署的 1 种新型夹。2 名研究者治疗了 45 个出血部位（每个设备在胃的不同随机部位有 15 个出血部位：胃底、胃体和胃窦）。
通过操作时间和达到止血所需的夹数量的终点来测量可用性。通过治疗前后压力升高（Δp）的终点来测量疗效。
所有 45 例止血治疗均成功完成。夹的平均操作时间在 3 种夹之间有显著差异，过镜应用夹达到止血所需的时间明显短于其他 2 种夹。达到止血所需的夹数量，过镜应用夹明显优于其他夹。测试的不同夹之间的压力变化（Δp±SD）也有显著差异。
体外研究。
在这项前瞻性、随机的体外研究中，我们观察到 3 种夹在可用性（达到止血所需的时间和所需的夹数量）和疗效（夹所产生的压力变化）方面有显著差异。过镜应用夹在达到止血所需的时间和所需的夹数量方面优于其他 2 种测试夹。
