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NCT06133023Not yet recruiting

WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts

WONDER-02: Plastic Stent vs. Lumen-apposing Metal Stent for Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts-a Multicentre Randomised Non-inferiority Trial

Source: ClinicalTrials.gov · Last updated 15 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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), the use of a LAMS is limited by its high costs and specific adverse events compared to plastic stent placement. 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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
29 Oct 2023
Start date
Nov 2023
Primary completion date
Oct 2026
Lead sponsor
Tokyo University
NCT number
NCT06133023

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From Nov 2023 to the primary completion date, Oct 2026
  • 26 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Coagulopathy (e.g., platelet count \< 50,000/mm3 or prothrombin time international normalised ratio \[PT-INR\] \>1.5)

Other

  • A pseudocyst that is inaccessible via the EUS-guided approach
  • A plastic or lumen-apposing metal stent in situ
  • Users of antithrombotic agents that cannot be discontinued according to the Japan Gastroenterological Endoscopy Society \[JGES\] guidelines
  • Patients who do not tolerate endoscopic procedures
  • Pregnant women

Who the study is looking for

  • Patients with pancreatic pseudocyst(s) defined by the revised Atlanta classification
  • The longest diameter of a targeted pseudocyst ≥ 5 cm
  • Patients requiring drainage for symptoms associated with a pseudocyst (e.g., infection, gastrointestinal symptoms including abdominal pain, or jaundice)
  • Patients aged 18 years or older
  • Written informed consent obtained from patients or their representatives

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Gastroenterology, Aichi Medical University
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AichiJapanUnknown status
Department of Gastroenterology, The University of Tokyo Hospital
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Bunkyō-Ku, TokyoJapanUnknown status
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
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Bunkyō-Ku, TokyoJapanUnknown status
Department of Gastroenterology, Graduate School of Medicine, Chiba University
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ChibaJapanUnknown status
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
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FukuokaJapanUnknown status
First Department of Internal Medicine, Gifu University Hospital
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GifuJapanUnknown status
Department of Gastroenterology, Gifu Municipal Hospital
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GifuJapanUnknown status
Department of Gastroenterology, Gifu Prefectural General Medical Center
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GifuJapanUnknown status
Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University
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HyōgoJapanUnknown status
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
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KagawaJapanUnknown status
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences
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KagoshimaJapanUnknown status
Department of Gastroenterology, Kameda Medical Center
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KamogawaJapanUnknown status
Department of Gastroenterology, St. Marianna University School of Medicine
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KanagawaJapanUnknown status
Department of Gastroenterological Endoscopy, Kanazawa Medical University
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KanazawaJapanUnknown status
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
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KawagoeJapanUnknown status
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
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KawasakiJapanUnknown status
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
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KobeJapanUnknown status
Department of Gastroenterology and Hepatology, Mie University Hospital
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MieJapanUnknown status
Department of Gastroenterology and Hepatology, Okayama University Hospital
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OkayamaJapanUnknown status
2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University
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OsakaJapanUnknown status
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
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ŌsakaJapanUnknown status
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
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SapporoJapanUnknown status
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
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TokyoJapanUnknown status
Third Department of Internal Medicine, University of Toyama
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ToyamaJapanUnknown status
Department of Gastroenterology, Wakayama Medical University School of Medicine
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WakayamaJapanUnknown status
Department of Gastroenterology, Yamanashi Prefectural Central Hospital
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YamanashiJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.