Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Fluid Collection | — | UNRESOLVED | — |
| Pancreatic Pseudocyst | — | UNRESOLVED | — |
| Pancreatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LAMS | Procedure | — | UNRESOLVED |
| Plastic stent | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Plastic stent group
- description
- In the plastic stent group, two (at least one) 7-Fr double pigtail stents will be placed. Following EUS-guided puncture of a pseudocyst, a guidewire will be coiled within the lesion, and another guidewire will be inserted alongside the prepositioned guidewire. The puncture tract will be dilated if needed.
- interventionNames
- Procedure: Plastic stent
- type
- ACTIVE_COMPARATOR
- label
- LAMS group
- description
- In the LAMS group, a LAMS with electrocautery enhanced delivery will be placed (Hot AXIOS; Boston Scientific Japan, Tokyo, Japan). A guidewire or dilator will be used if needed.
- interventionNames
- Procedure: LAMS
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (2)
- BACKGROUNDBanks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25. PMID 23100216
- DERIVEDSaito T, Takenaka M, Kuwatani M, Doi S, Ohyama H, Fujisawa T, Masuda A, Iwashita T, Shiomi H, Hayashi N, Iwata K, Maruta A, Mukai T, Matsubara S, Hamada T, Inoue T, Matsumoto K, Hirose S, Fujimori N, Kashiwabara K, Kamada H, Hashimoto S, Shiratori T, Yamada R, Kogure H, Nakahara K, Ogura T, Kitano M, Yasuda I, Isayama H, Nakai Y; WONDERFUL study group in Japan and collaborators. 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. Trials. 2024 Aug 24;25(1):559. doi: 10.1186/s13063-024-08373-6. PMID 39182137