未经证实:在我们之前的研究中,我们开发了一种用于肺结节切除的四钩爪线定位装置,获得了满意的结果。在此之后,我们进行了这个单中心,开放标签,随机临床试验,比较这种新型定位装置和目前广泛使用的钩针的成功率和并发症发生率。
UNASSIGNED:在上海胸科医院接受术前定位和胸腔镜切除的肺小结节(0.4-1厘米)患者被随机分配(1:2比例,通过计算机生成的随机数)使用新型的爪缝合系统(爪组)或经典(钩针组)定位设备进行定位。这项研究的主要终点是定位成功率,次要终点包括并发症,本地化相关时间,和痛苦。
UNASSIGNED:在胸腔镜切除肺小结节之前,将411例患者随机分配到爪组(n=136)或钩针组(n=275)并进行分析。与钩针组相比,爪组的成功率明显更高(133/136,97.8%vs.254/275,92.4%,P=0.027),无症状出血较少(16.9%vs.37.5%,P=0.003)和胸膜反应(0%vs.5.1%,P=0.017),以及定位后10分钟更好的疼痛缓解(使用两个视觉模拟量表评分之间的差异测量,0.84±0.98vs.0.35±0.79,P<0.001)。相比之下,钩针组的定位过程持续时间短于爪组(7.2±2.9vs.14.4±6.6min,P<0.001)。在多个定位子群中,与钩针组相比,爪组也取得了更高的成功率(32/33,97.0%vs.70/86,81.4%)和较少的胸膜反应(0%vs.16.3%)。
UNASSIGNED:新的爪-缝线定位装置优于传统的钩针,成功率更高,并发症少,和更好的患者对肺小结节术前定位的耐受性。
UASSIGNED:中国临床试验注册中心ChiCTR1900027346。
UNASSIGNED: In our previous study, we developed a 4-hook claw-suture localization device for pulmonary nodule resection, which acheived satifisfactory results. Following this, we conducted this single-center, open-label, randomized clinical trial to compare the success rate and complication rate of this novel localization device and currently widely-used hookwire.
UNASSIGNED: Patients with small pulmonary nodules (0.4-1 cm) who received preoperative localization and thoracoscopic resection at Shanghai Chest Hospital were randomly assigned (1:2 ratio, via computer-generated randomized numbers) to undergo localization using either a novel claw-suture system (claw group) or classical (hookwire group) localization device. The primary endpoint of this study was localization success rate, and the secondary endpoints included complications, localization-related time, and pain.
UNASSIGNED: A total of 411 patients were randomly assigned to the claw group (n=136) or the hookwire group (n=275) before thoracoscopic resection of small pulmonary nodules and analyzed. Compared with the hookwire group, the claw group had a significantly higher success rate (133/136, 97.8% vs. 254/275, 92.4%, P=0.027), less asymptomatic hemorrhage (16.9% vs. 37.5%, P=0.003) and pleural reaction (0% vs. 5.1%, P=0.017), as well as better pain alleviation 10 min after localization (measured using the difference between two visual analog scale scores, 0.84±0.98 vs. 0.35±0.79, P<0.001). In contrast, the hookwire group was associated with a shorter localization procedure duration than the claw group (7.2±2.9 vs. 14.4±6.6 min, P<0.001). In the multiple localization subgroup, the claw group compared to the hookwire group also achieved higher success (32/33, 97.0% vs. 70/86, 81.4%) and less pleural reaction (0% vs. 16.3%).
UNASSIGNED: The new claw-suture localization device is superior to traditional hookwire, with a higher success rate, fewer complications, and better patient tolerance for preoperative localization of small pulmonary nodules.
UNASSIGNED: Chinese Clinical Trial Registry ChiCTR1900027346.