| Autor: |
Tomotaka Saito, Mamoru Takenaka, Masaki Kuwatani, Shinpei Doi, Hiroshi Ohyama, Toshio Fujisawa, Atsuhiro Masuda, Takuji Iwashita, Hideyuki Shiomi, Nobuhiko Hayashi, Keisuke Iwata, Akinori Maruta, Tsuyoshi Mukai, Saburo Matsubara, Tsuyoshi Hamada, Tadahisa Inoue, Kazuyuki Matsumoto, Sumio Hirose, Nao Fujimori, Kosuke Kashiwabara, Hideki Kamada, Shinichi Hashimoto, Toshiyasu Shiratori, Reiko Yamada, Hirofumi Kogure, Kazunari Nakahara, Takeshi Ogura, Masayuki Kitano, Ichiro Yasuda, Hiroyuki Isayama, Yousuke Nakai, for the WONDERFUL study group in Japan and collaborators |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
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| Zdroj: |
Trials, Vol 25, Iss 1, Pp 1-14 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
1745-6215 |
| DOI: |
10.1186/s13063-024-08373-6 |
| Popis: |
Abstract 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. Discussion 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. Trial registration ClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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