Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan.
Trials. 2024 Aug 24;25(1):559. doi: 10.1186/s13063-024-08373-6.
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.
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.
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.
ClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.
内镜超声 (EUS)-引导下经腔引流已成为治疗有症状胰腺假性囊肿的一线治疗方法。尽管 lumen-apposing 金属支架 (LAMS) 的应用越来越普及，但塑料支架可能以更低的成本有效地解决非坏死性积液积聚，且无 LAMS 相关不良事件。迄今为止，在这种情况下，关于适当支架类型的数据很少。本试验旨在评估在初始 EUS 引导下引流假性囊肿时，塑料支架与 LAMS 的非劣效性。
WONDER-02 试验是一项多中心、开放标签、非劣效性、随机对照试验，将在日本的 26 个中心招募需要 EUS 治疗的胰腺假性囊肿患者。该试验计划招募 80 名患者，他们将以 1:1 的比例随机分为塑料支架组或 LAMS 组（每组 40 名患者）。在塑料支架组中，将使用两根 7Fr 双猪尾支架进行 EUS 引导下引流。在 LAMS 组中，将以相同的方式进行治疗，只是使用 LAMS。根据试验研究者的判断，将通过内镜和/或经皮程序进行升级治疗。主要终点是临床成功率，定义为假性囊肿大小降至≤2cm 和炎症指标（即体温、白细胞计数和血清 C 反应蛋白）改善。次要终点包括技术成功率、包括死亡率、假性囊肿复发和医疗费用在内的不良事件。
WONDER-02 试验将研究与 LAMS 相比，塑料支架在 EUS 引导下治疗有症状胰腺假性囊肿的疗效和安全性，特别关注塑料支架的非劣效疗效。研究结果将有助于为这一人群建立新的治疗方案。
ClinicalTrials.gov NCT06133023 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。
