背景:内镜超声(EUS)引导的腔内引流已成为有症状的胰腺假性囊肿的一线治疗方式。尽管管腔贴壁金属支架(LAMSs)越来越受欢迎,塑料支架可有效解决非坏死液体收集,成本较低,且无LAMS特异性不良事件.迄今为止,在这种情况下,关于适当支架类型的数据很少。该试验旨在评估塑料支架对LAMS的非劣效性,用于最初的EUS引导的假性囊肿引流。
方法:WONDER-02试验是一项多中心试验,开放标签,非自卑,随机对照试验,这将在日本26个中心招募需要EUS指导治疗的胰腺假性囊肿患者。该试验计划招募80名患者,这些患者将以1:1的比例随机接受塑料支架或LAMS(每臂40名患者)。在塑料支架组中,EUS引导的引流将使用两个7-Fr双纤尾支架进行。在LAMS组中,除使用LAMS外,治疗将以相同的方式进行.根据试验研究者的判断,将通过内窥镜和/或经皮手术进行强化治疗。主要终点是临床成功,这被定义为假性囊肿大小减小至≤2厘米,炎症指标改善(即体温,白细胞计数,和血清C反应蛋白)。次要终点包括技术成功,不良事件包括死亡率,假性囊肿复发,和医疗费用。
结论:WONDER-02试验将研究塑料支架与LAMS相比在EUS指导的有症状胰腺假性囊肿治疗中的疗效和安全性,特别关注塑料支架的非低劣疗效。这些发现将有助于为该人群建立新的治疗算法。
背景:ClinicalTrials.govNCT06133023于2023年11月9日注册。UMIN000052647于2023年10月30日注册。jRCT1032230444于2023年11月7日注册。
BACKGROUND: Endoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts.
METHODS: The WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator\'s discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs.
CONCLUSIONS: The WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population.
BACKGROUND: ClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.