Status:
NOT_YET_RECRUITING
WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts
Lead Sponsor:
Tokyo University
Conditions:
Pancreatic Fluid Collection
Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 st...
Detailed Description
Pancreatic fluid collections (PFCs) develop as local complications of acute pancreatitis after four weeks of the disease onset. Pancreatic pseudocysts are a type of PFC, which is characterised by enca...
Eligibility Criteria
Inclusion
- 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
Exclusion
- A pseudocyst that is inaccessible via the EUS-guided approach
- A plastic or lumen-apposing metal stent in situ
- Coagulopathy (e.g., platelet count \< 50,000/mm3 or prothrombin time international normalised ratio \[PT-INR\] \>1.5)
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2033
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06133023
Start Date
November 1 2023
End Date
September 1 2033
Last Update
November 15 2023
Active Locations (26)
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1
Department of Gastroenterology, Aichi Medical University
Aichi, Japan
2
Department of Gastroenterology, The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan, 113-8655
3
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Bunkyō-Ku, Tokyo, Japan
4
Department of Gastroenterology, Graduate School of Medicine, Chiba University
Chiba, Japan