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

UMIN ID: UMIN000052647

Registered date:30/10/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Pancreatic Pseudocyst
• Date of first enrollment: 2023/11/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
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.

Outcome(s)

• Primary Outcome: Clinical success within 180 days of randomisation
• Secondary Outcome: -Adverse events -Mortality -Technical success rate of initial EUS-PCD (Endoscopic ultrasonography-guided pseudocyst drainage) -Incidence of biliary and gastrointestinal stricture -Number and time of interventions -Indwelling time of endoscopic and percutaneous drainage -Time to success -Success rate and operation time of surgical procedures -Hospital stay and ICU stay -Duration of antibiotics administration -Cost of interventions and hospital stay -Recurrence of WON -Time to recurrence of WON -Treatment duration of recurrent WON -New onset of pseudocyst -Treatment duration of new-onset pseudocyst -Incidence of new-onset diabetes, clinical symptoms of pancreatic exocrine insufficiency, and pancreatic cancer -The presence and timing of medications for pancreatic exocrine insufficiency -The presence and timing of sarcopenia -Morphological change of pancreas

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: The University of Tokyo
• Source(s) of Monetary Support: None
• Secondary ID(s): 2023002P