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
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gastroenterology, Aichi Medical University Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| Department of Gastroenterology, The University of Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō-Ku, Tokyo | Japan | Unknown status |
| Department of Gastroenterology, Graduate School of Medicine, Juntendo University Coordinator of this site? Confirm its status | Bunkyō-Ku, Tokyo | Japan | Unknown status |
| Department of Gastroenterology, Graduate School of Medicine, Chiba University Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| First Department of Internal Medicine, Gifu University Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| Department of Gastroenterology, Gifu Municipal Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| Department of Gastroenterology, Gifu Prefectural General Medical Center Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University Coordinator of this site? Confirm its status | Hyōgo | Japan | Unknown status |
| Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University Coordinator of this site? Confirm its status | Kagawa | Japan | Unknown status |
| Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Department of Gastroenterology, Kameda Medical Center Coordinator of this site? Confirm its status | Kamogawa | Japan | Unknown status |
| Department of Gastroenterology, St. Marianna University School of Medicine Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Department of Gastroenterological Endoscopy, Kanazawa Medical University Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University Coordinator of this site? Confirm its status | Kawagoe | Japan | Unknown status |
| Department of Gastroenterology, Teikyo University Mizonokuchi Hospital Coordinator of this site? Confirm its status | Kawasaki | Japan | Unknown status |
| Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Department of Gastroenterology and Hepatology, Mie University Hospital Coordinator of this site? Confirm its status | Mie | Japan | Unknown status |
| Department of Gastroenterology and Hepatology, Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| 2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine Coordinator of this site? Confirm its status | Ōsaka | Japan | Unknown status |
| Department of Gastroenterology and Hepatology, Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Third Department of Internal Medicine, University of Toyama Coordinator of this site? Confirm its status | Toyama | Japan | Unknown status |
| Department of Gastroenterology, Wakayama Medical University School of Medicine Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| Department of Gastroenterology, Yamanashi Prefectural Central Hospital Coordinator of this site? Confirm its status | Yamanashi | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.