Endoscopic Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Endoscopic Unit, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Milan, Italy.
Gastrointest Endosc. 2022 Nov;96(5):780-786. doi: 10.1016/j.gie.2022.06.004. Epub 2022 Jun 8.
OverStitch devices (OverStitch and OverStitch Sx; Apollo Endosurgery, Inc, Austin, Tex, USA) are used for a wide range of applications. A European registry was created to prospectively collect technical and clinical data regarding both systems to provide procedural outcomes and to find correlation between procedural characteristics and outcomes. This study shows the initial results of the first 3 years of the registry.
Patients who underwent endoscopic suturing from January 2018 to January 2021 at 9 centers were enrolled. Data regarding the disease treated,suturing pattern and outcomes were registered. Technical feasibility (success reaching the target area), technical success (success placing sutures), and clinical success (complete resolution of the clinical issue) were recorded and analyzed.
During the study period, 137 patients (57.7% men) were enrolled with 100% technical feasibility rate. Endoscopic suturing was successfully performed in 136 cases (16.7% with OverStitch Sx), obtaining a technical success rate of 99.3%. No adverse events were recorded. Overall clinical success was 89%. Mucosal defects were sutured in 32 patients (100% clinical success). Leaks/fistulas were treated in 23 patients (64.7% clinical success). The clinical success of stent fixations (n = 38) was 85%. Perforations (n = 22) were repaired with a clinical success of 94.7%. No significant correlation between location, suture pattern or number, and the success was found, except in case of fistulas where fistulas <1 cm treated by a continuous suture were more likely to achieve clinical success in the follow-up (P < .001).
OverStitch-based suturing is technically feasible regardless of site and method of suturing, with no cases of failure. The overall technical success rate of 99.3% and the clinical outcome success rate of 89% demonstrate that OverStitch technology provides reliable suturing with clinical advantages, especially with fistulas <1 cm.
OverStitch 装置（OverStitch 和 OverStitch Sx；Apollo Endosurgery，Inc，美国德克萨斯州奥斯汀）可用于广泛的应用。创建了一个欧洲注册处，前瞻性地收集两个系统的技术和临床数据，以提供手术结果，并找到手术特征与结果之间的相关性。本研究展示了该注册处最初 3 年的结果。
在 9 个中心，2018 年 1 月至 2021 年 1 月期间，对接受内镜缝合的患者进行了登记。登记了治疗疾病、缝合模式和结果的数据。记录并分析了技术可行性（成功到达目标区域）、技术成功率（成功放置缝线）和临床成功率（临床问题完全解决）。
在研究期间，共纳入 137 例患者（57.7%为男性），100%的技术可行性。136 例患者成功实施了内镜缝合术（16.7%使用了 OverStitch Sx），技术成功率为 99.3%。无不良事件发生。总体临床成功率为 89%。32 例患者的黏膜缺损被缝合（100%的临床成功率）。23 例漏/瘘患者接受治疗（64.7%的临床成功率）。38 例支架固定的临床成功率为 85%。22 例穿孔的临床成功率为 94.7%。除瘘管外，未发现位置、缝合方式或数量与成功率之间有显著相关性，在瘘管<1cm 的情况下，连续缝合治疗的瘘管更有可能在随访中获得临床成功（P<.001）。
无论缝合部位和方法如何，基于 OverStitch 的缝合技术都是可行的，没有失败的情况。99.3%的总体技术成功率和 89%的临床结果成功率表明，OverStitch 技术提供了可靠的缝合，具有临床优势，特别是在瘘管<1cm 的情况下。
