Ramai Daryl, Deliwala Smit S, Mozell Daniel, Facciorusso Antonio, Chandan Saurabh, Persaud Alana, Singh Kelita, Anderloni Andrea, Barakat Monique T
Division of Gastroenterology, Hepatology, and Nutrition, University of Utah Health, Salt Lake City, UT.
Department of Internal Medicine, Michigan State University at Hurley Medical Center, Flint, MI.
J Clin Gastroenterol. 2024 Jan 1;58(1):76-79. doi: 10.1097/MCG.0000000000001822.
Clips are endoscopic mechanical devices with tensile and closure strength that can approximate tissue and provide hemostasis through a tamponade effect. Clips are ubiquitously used in endoscopic practice, and numerous studies have validated the clinical efficacy of clips, with recent guidelines recommending them as a first-line intervention for recurrent and persistent nonvariceal gastrointestinal bleeding. However, the safety profile for these devices has yet to be delineated, thus, we aim to investigate this feature by examining the adverse events reported to the Food and Drug Administration.
Postmarketing surveillance data from the Food and Drug Administration Manufacturer And User Facility Device Experience database were analyzed from January 2012 to January 2021. The Manufacturer And User Facility Device Experience database is a reporting software and does not independently verify the details of complications.
Two thousand five hundred forty reports were issued, of which 287 were patient adverse events and 2766 were device problems. Activation, separation, and positioning issues were most common. No consequences or clinically significant impact on patients were seen in 1968 reports. Foreign bodies were seen in 97 cases, hemorrhage in 57 cases, tissue damage in 42 cases, embedded clips in tissues/plaques in 16 cases, perforation in 15 cases, lacerations in 6 cases, and infection in 3 cases.
While the most commonly reported device problems involved activation, separation, and positioning, most patients were clinically unaffected. Moreover, perforation and infection were exceedingly rare, further highlighting the safety profile of endoscopic clips.
夹子是一种内镜机械装置，具有拉伸和闭合强度，可使组织靠拢，并通过填塞效应实现止血。夹子在内镜操作中广泛应用，众多研究已证实其临床疗效，近期指南推荐将其作为复发性和持续性非静脉曲张性胃肠道出血的一线干预措施。然而，这些装置的安全性尚未明确，因此，我们旨在通过审查向美国食品药品监督管理局报告的不良事件来研究这一特性。
分析了2012年1月至2021年1月期间美国食品药品监督管理局制造商和用户设施设备经验数据库的上市后监测数据。制造商和用户设施设备经验数据库是一个报告软件，并不独立核实并发症的细节。
共发布了2540份报告，其中287份为患者不良事件，2766份为设备问题。激活、分离和定位问题最为常见。1968份报告中未观察到对患者的后果或临床显著影响。发现97例有异物，57例出血，42例组织损伤，16例夹子嵌入组织/斑块，15例穿孔，6例撕裂伤，3例感染。
虽然最常报告的设备问题涉及激活、分离和定位，但大多数患者在临床上未受影响。此外，穿孔和感染极为罕见，进一步凸显了内镜夹子的安全性。
