WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts-study protocol for a multicentre randomised non-inferiority trial

• Published in: Current controlled trials in cardiovascular medicine 2024-08, Vol.25 (1), p.559-14
• Main Authors: Saito, Tomotaka, Takenaka, Mamoru, Kuwatani, Masaki, Doi, Shinpei, Ohyama, Hiroshi, Fujisawa, Toshio, Masuda, Atsuhiro, Iwashita, Takuji, Shiomi, Hideyuki, Hayashi, Nobuhiko, Iwata, Keisuke, Maruta, Akinori, Mukai, Tsuyoshi, Matsubara, Saburo, Hamada, Tsuyoshi, Inoue, Tadahisa, Matsumoto, Kazuyuki, Hirose, Sumio, Fujimori, Nao, Kashiwabara, Kosuke, Kamada, Hideki, Hashimoto, Shinichi, Shiratori, Toshiyasu, Yamada, Reiko, Kogure, Hirofumi, Nakahara, Kazunari, Ogura, Takeshi, Kitano, Masayuki, Yasuda, Ichiro, Isayama, Hiroyuki, Nakai, Yousuke
• Format: Article
• Language: English
• Subjects: Adult; Antibiotics; Blood cell count; Care and treatment; Clinical trials; Costs; Cysts; Diabetes; Drainage; Drainage - adverse effects; Drainage - instrumentation; Drainage - methods; Endoscopic ultrasonography; Endoscopy; Endosonography; Endosonography - methods; Equivalence Trials as Topic; Health aspects; Hemoglobin; Humans; Japan; Male; Metals; Morphology; Mortality; Multicenter Studies as Topic; Pancreatic cancer; Pancreatic fistula; Pancreatic pseudocyst; Pancreatic Pseudocyst - diagnostic imaging; Pancreatic Pseudocyst - surgery; Pancreatic Pseudocyst - therapy; Pancreatitis; Plastics; Sarcopenia; Stent (Surgery); Stents; Success; Treatment Outcome; Ultrasonic imaging; Ultrasonography, Interventional
• ISSN: 1745-6215; 1745-6215
• 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.