Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis: a Randomized Trial (WONDER-01)

UMIN ID: UMIN000048310

Registered date:07/07/2022

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Walled-off necrosis
• Date of first enrollment: 2022/06/27
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

[Immediate necrosectomy group] Endoscopic necrosectomy will be conducted in the same session of EUS-guided drainage (or at least within 72 hours of randomization) and be repeated until clinical success.
[Step-up approach group] Step-up treatment will be conducted if a patient's condition does not improve after EUS-guided drainage. The step-up approach includes increasing the number of stents, adding another EUS-guided drainage, and performing percutaneous drainage after 72-96 hours of the initial drainage. Endoscopic necrosectomy is considered when clinical improvement is not observed even after two times of step-up treatment.

Outcome(s)

• Primary Outcome: Time to clinical success from randomization
• 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 -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: -WON inaccessible by EUS-guided approach -AXIOS stent has already been placed into the WON prior to the enrollment -Severe coagulopathy; Platelet count < 50,000/mm3 or prothrombin time international normalized ratio (PT-INR) >1.5 -Patients on antithrombotic agents which cannot be managed according to the "guideline for gastroenterological endoscopy in patients undergoing antithrombotic treatment (Dig Endosc. 2014 Jan;26(1):1-14.)" -Patients who cannot tolerate endoscopic procedures -Pregnant women -Patients considered inappropriate for inclusion by investigators

Related Information

• Primary Sponsor: Graduate School of Medicine, The University of Tokyo
• Source(s) of Monetary Support: None
• Secondary ID(s): 2021005P,jRCT1032220055