WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts: a multicentre randomised non-inferiority trial

WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts: a multicentre randomised non-inferiority trial - WONDER-02 study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1032230444

Enrollment

Registered

2023-11-10

Start date

2023-11-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic pancreatic pseudocyst acute pancreatitis, pancreatic pseudocyst, pancreatic fluid collection, postoperative pancreatic fluid collection

Interventions

Patients are randomised to two groups bleow. EUS-guided drainage will be conducted under endosonographic and fluoroscopic guidance within 72 hours of the randomisation. A linear echoendoscope will b

D004322

Endoscopic ultrasound-guided pancreatic drainage, sep-up intervention

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with pancreatic pseudocyst(s) defined by the revised Atlanta classification -The longest diameter of a targeted pseudocyst more than 5 cm -Patients requiring drainage for symptoms associated with a pseudocyst -Patients aged 18 years or older -Written informed consent obtained from patients or their representatives

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
Rate of clinical success	—

Secondary

Measure	Time frame
-Adverse events -Mortality -Rate of technical success -Incidence of biliary stricture and gastrointestinal stricture -Number and time of interventions -Indwelling time of endoscopic drainage and percutaneous drainage -Success rate of surgical procedures -Operation time of surgical procedures -Hospital and ICU stay -Duration of antibiotics administration -Costs -Recurrence of pancreatic pseudocyst -Time to recurrence of pancreatic pseudocyst -Treatment duration of recurrent pancreatic pseudocyst -New onset of pancreatic fluid collection -Treatment duration of new onset pancreatic fluid collection -Incidence of new onset diabetes -The presence of medications for pancreatic exocrine insufficiency -The presence of sarcopenia -Morphological change of pancreas -Time to clinical success	—

Measure

Time frame

-Adverse events -Mortality -Rate of technical success -Incidence of biliary stricture and gastrointestinal stricture -Number and time of interventions -Indwelling time of endoscopic drainage and percutaneous drainage -Success rate of surgical procedures -Operation time of surgical procedures -Hospital and ICU stay -Duration of antibiotics administration -Costs -Recurrence of pancreatic pseudocyst -Time to recurrence of pancreatic pseudocyst -Treatment duration of recurrent pancreatic pseudocyst -New onset of pancreatic fluid collection -Treatment duration of new onset pancreatic fluid collection -Incidence of new onset diabetes -The presence of medications for pancreatic exocrine insufficiency -The presence of sarcopenia -Morphological change of pancreas -Time to clinical success

—

Contacts

Public ContactTomotaka Saito

Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

tomsaito-gi@umin.ac.jp+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026