Abstract:
Background and study aims Endoscopic through-the-scope clips (TTSC) are used for hemostasis and closure. We documented the performance of a new TTSC with anchor prongs. Patients and methods We conducted a prospective case series of the new TTSC in 50 patients with an indication for endoscopic clipping at three hospitals in the United States and Canada. Patients were followed for 30 days after the index procedure. Outcomes included defect closure and rate of serious adverse events (SAEs) related to the device or procedure. Results Fifty patients had 56 clipping procedures. Thirty-four procedures were clipping after endoscopic mucosal resection (EMR) in the colon (33) or stomach (1), 16 after polypectomy, two for hemostasis of active bleeding, and one each for fistula closure, per-oral endoscopic myotomy mucosal closure, or anchoring a feeding tube. Complete defect closure was achieved in 32 of 33 colon EMR defects and 21 of 22 other defects. All clips were placed per labeled directions for use. In 41 patients (82.0%), prophylaxis of delayed bleeding was reported as an indication for endoscopic clipping. There were three instances of delayed bleeding. There were no device-related SAEs. The only technical difficulty was one instance of premature clip deployment. Conclusions A novel TTSC with anchor prongs showed success in a range of defect closures, an acceptable safety profile, and low incidence of technical difficulties.
摘要:
背景和研究目的内镜下夹(TTSC)用于止血和闭合。我们记录了带有锚叉的新TTSC的性能。患者和方法我们在美国和加拿大的三家医院对50名具有内窥镜夹闭适应症的患者进行了新的TTSC的前瞻性病例系列。在索引程序后对患者进行30天的随访。结果包括与装置或手术相关的缺陷闭合和严重不良事件(SAE)的发生率。结果50例患者共进行了56次夹闭手术。在结肠(33)或胃(1)的内镜粘膜切除术(EMR)后,进行了34次手术,16息肉切除术后,两个用于活动性出血的止血,每个一个用于瘘管闭合,经口内镜肌切开术粘膜闭合术,或锚定饲管。在33个结肠EMR缺损中的32个和22个其他缺损中的21个中实现了完全缺损闭合。所有夹子都按照标记的使用方向放置。41例患者(82.0%),据报道,预防延迟性出血是内镜下夹闭的适应症.有三例延迟出血。没有与设备相关的严重不良事件。唯一的技术困难是过早部署剪辑的一个实例。结论一种新型的带有锚叉的TTSC在一系列缺损闭合中显示出成功的效果。可接受的安全概况,技术难题发生率低。