背景:肺癌是全球最常见的恶性肿瘤之一。通过电视辅助胸腔镜手术(VATS)进行的解剖肺癌切除术的数量正在迅速增长。订书机广泛用于VATS程序,但是关于它们如何影响性能和术后结果的临床数据有限,包括漏气.这项临床试验评估了在VATS肺切除术中使用动力吻合器,主要研究终点是漏气和长期漏气(PAL)的发生和持续时间。
方法:从单臂收集数据,在接受VATS楔形切除术或肺叶切除术的中国患者中进行的多中心研究。术中数据包括手术时间;支气管结扎/横切的药筒选择,主要船只,和肺实质;主治线干预;失血;和设备使用。术后数据包括空气泄漏评估,胸管持续时间,住院时间,和不良事件(AE)。
结果:最终分析包括了中国四个机构的94例手术:15例楔形切除术,74个肺活瘤,和五个楔形切除,然后是肝切除术。5例(5.3%)肺叶切除术后漏气,1例(1.1%)患者使用PAL。相对于组织类型的药筒使用,位点通常是一致的。需要手术干预的吻合器射击的发生率为550人中的7人(1.3%)。参与研究的外科医生对订书机的关节和整体可用性感到满意。
结论:动力吻合器使VATS手术对于外科医生来说更容易,并且获得了与先前报道的患者手术中和术后结果相当的结果。
BACKGROUND: Lung cancer is one of the most prevalent malignancies worldwide. The number of anatomic lung cancer resections performed via video-assisted thoracoscopic surgery (VATS) is growing rapidly. Staplers are widely used in VATS procedures, but there is limited clinical data regarding how they might affect performance and postoperative outcomes, including air leak. This clinical trial assessed the use of a powered stapler in VATS lung resection, with a primary study endpoint being occurrence and duration of air leak and prolonged air leak (PAL).
METHODS: Data was collected from a single arm, multi-center study in Chinese patients receiving VATS wedge resection or lobectomy. Intra-operative data included surgery duration; cartridge selection for ligation/transection of bronchus, major vessels, and lung parenchyma; staple line interventions; blood loss; and device usage. Post-operative data included air leak assessments, chest tube duration, length of hospital stay, and adverse events (AEs).
RESULTS: A total of 94 procedures across four institutions in
China were included in the final analysis: 15 wedge resections, 74 lobectomies, and five wedge resections followed by lobectomies. Post-operative air leak occurred in five (5.3%) patients who had lobectomy procedures, with PAL in one (1.1%) patient. Sites were generally consistent relative to cartridge use by tissue type. The incidence of stapler firings requiring surgical interventions was seven out of 550 (1.3%). Surgeons participating in the study were satisfied with the
articulation and overall usability of the stapler.
CONCLUSIONS: The powered staplers make the VATS procedure easier for the surgeons and have achieved intra- and post-operative patient outcomes comparable to those previously reported.