Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis: a Randomized Trial (WONDER-01)
Not Applicable
- Conditions
- Walled-off necrosis
- Registration Number
- JPRN-UMIN000048310
- Lead Sponsor
- Graduate School of Medicine, The University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to clinical success from randomization
- Secondary Outcome Measures
Name Time Method -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