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

JRCT ID: jRCT1032230444

Registered date:10/11/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Symptomatic pancreatic pseudocyst
• Date of first enrollment: 10/11/2023
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Patients are randomised to two groups bleow.

<Plastic stent group>
EUS-guided drainage will be conducted under endosonographic and fluoroscopic guidance within 72 hours of the randomisation. A linear echoendoscope will be advanced to the stomach or duodenum with moderate sedation, and the targeted pseudocyst will be visualised and punctured under endosonographic guidance. Prophylactic antibiotics may be administered at the trial investigator's discretion. In cases with an insufficient improvement in inflammatory indicators (i.e., body temperature, white blood cell count, and C-reactive protein), we will perform additional interventions including the addition of or replacement with a plastic stent or LAMS and/or percutaneous drainage if needed. 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.

<LAMS group>
EUS-guided drainage will be conducted under endosonographic and fluoroscopic guidance within 72 hours of the randomisation. A linear echoendoscope will be advanced to the stomach or duodenum with moderate sedation, and the targeted pseudocyst will be visualised and punctured under endosonographic guidance. Prophylactic antibiotics may be administered at the trial investigator's
discretion. In cases with an insufficient improvement in inflammatory indicators (i.e., body temperature, white blood cell count, and C-reactive protein), we will perform additional interventions including the addition of or replacement with a plastic stent or LAMS and/or percutaneous drainage if needed. 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.

Outcome(s)

• Primary Outcome: Rate of clinical success

Secondary Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

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: Nakai Yousuke