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.
Drainage
Endoscopy
Endosonography
Mortality
Pancreatic fistula
Pancreatic pseudocyst
Pancreatitis
Randomised clinical trial
Sepsis
Stents
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
24 Aug 2024
24 Aug 2024
Historique:
received:
25
02
2024
accepted:
05
08
2024
medline:
26
8
2024
pubmed:
26
8
2024
entrez:
24
8
2024
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
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
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
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.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.
Identifiants
pubmed: 39182137
doi: 10.1186/s13063-024-08373-6
pii: 10.1186/s13063-024-08373-6
doi:
Substances chimiques
Plastics
0
Metals
0
Banques de données
ClinicalTrials.gov
['NCT06133023']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
559Investigateurs
Shunsuke Omoto
(S)
Shinya Uemura
(S)
Ryota Nakano
(R)
Yuta Kawase
(Y)
Sho Takahashi
(S)
Mitsuru Okuno
(M)
Yuhei Iwasa
(Y)
Kensaku Yoshida
(K)
Shogo Ota
(S)
Masahiro Tsujimae
(M)
Arata Sakai
(A)
Kentaro Suda
(K)
Naminatsu Takahara
(N)
Kazunaga Ishigaki
(K)
Ryunosuke Hakuta
(R)
Tatsuya Sato
(T)
Rena Kitano
(R)
Motoyasu Kan
(M)
Hiroki Nagashima
(H)
Yotaro Iino
(Y)
Koji Takahashi
(K)
Kazumichi Kawakubo
(K)
Ryo Sugiura
(R)
Kazuma Kishi
(K)
Hiroki Yonemura
(H)
Shunichiro Nozawa
(S)
Ryota Nakabayashi
(R)
Namima Daisuke
(N)
Makoto Hinokuchi
(M)
So Nakaji
(S)
Kenji Nose
(K)
Kei Saito
(K)
Shuzo Nomura
(S)
Mariko Fujisawa
(M)
Nobuyuki Kuniyoshi
(N)
Atsushi Okuda
(A)
Saori Ueno
(S)
Akira Miyano
(A)
Nobu Nishioka
(N)
Yusuke Satta
(Y)
Nobuhiro Katsukura
(N)
Masahiro Itonaga
(M)
Reiko Ashida
(R)
Takashi Tamura
(T)
Takahiro Shishimoto
(T)
Yuki Kawaji
(Y)
Hironari Kato
(H)
Ryosuke Sato
(R)
Keijiro Ueda
(K)
Katsuhito Teramatsu
(K)
Kazuhide Matsumoto
(K)
Informations de copyright
© 2024. The Author(s).
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