Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.
Sci Rep. 2023 May 11;13(1):7637. doi: 10.1038/s41598-023-34846-w.
A clinical efficacy study of 0.025-inch guidewires (GWs) according to mechanical property analysis has not been reported yet. This study was designed to evaluate the clinical efficacy of a newly developed 0.025-inch GW for biliary access according to the basic mechanical property. Commercially available 0.025-inch GWs were in vitro tested based on parameters of mechanical property. Patients with naïve papilla requiring diagnostic or therapeutic ERCP were randomly assigned to an experimental 0.025-inch newly developed GW or a control 0.025-inch GW group. Technical success rate of wire-guided cannulation (WGC), difficult biliary cannulation (DBC), and adverse event rates were measured in this multicenter randomized trial. The technical success rate of primary WGC was 79.1% (151 of 191) in the experimental group and 70.8% (131 of 185) in the control group (95% two-sided confidence interval: 8.25%; p < 0.001; for a noninferiority margin of 15%). The technical success rate including cross-over to each other was also non-inferior. However, the chi-square test showed a statistical difference (81.7% vs. 68.1%; p = 0.002). Median biliary cannulation time was shorter in the experimental group (53 s vs. 77 s; p = 0.047). The rate of DBC was more frequent in the control group (34.6% vs. 50.3% p = 0.002). Multivariate analysis revealed that control group was one of contributing factors for DBC. Overall rate of post-ERCP pancreatitis was not different (4.7% vs. 8.6%; p = 0.125). WGC using a newly developed GW with superior physical performance GW in a bench test showed similar clinical efficacy and the rate of DBC was significantly lower in experimental GW.
目前尚未有关于根据机械性能分析对 0.025 英寸导丝（GW）进行临床疗效研究的报道。本研究旨在根据基本机械性能评估一种新开发的用于胆道入路的 0.025 英寸 GW 的临床疗效。对市售的 0.025 英寸 GW 进行了基于机械性能参数的体外测试。将需要诊断或治疗性 ERCP 的初发乳头患者随机分配到实验组（新开发的 0.025 英寸 GW）和对照组（0.025 英寸 GW）。多中心随机试验中测量了导丝引导下胆管插管（WGC）、困难胆管插管（DBC）和不良事件发生率的技术成功率。实验组的原发性 WGC 技术成功率为 79.1%（151/191），对照组为 70.8%（131/185）（95%双侧置信区间：8.25%；p<0.001；非劣效性边界为 15%）。包括相互交叉的技术成功率也不劣于对照组。然而，卡方检验显示存在统计学差异（81.7%比 68.1%；p=0.002）。实验组的胆管插管中位时间更短（53 秒比 77 秒；p=0.047）。对照组的 DBC 发生率更高（34.6%比 50.3%；p=0.002）。多变量分析显示对照组是 DBC 的一个促成因素。总的术后胰腺炎发生率无差异（4.7%比 8.6%；p=0.125）。在体外测试中，具有优越物理性能的新型 GW 进行的 WGC 显示出相似的临床疗效，且实验组 GW 的 DBC 发生率显著降低。
