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Comparing Fully Covered, Self Expanding Metal Stent (FCSEMS) and Plastic Stents for EUS- Guided Drainage of WON

Indiana University · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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This is a multi-center, single-blinded, randomized trial comparing AXIOS FCSEMS (Fully Covered Self Expanding Metal Stent) and plastic stents for EUS (Endoscopic Ultrasound)-guided management of infected and/or symptomatic WON (Walled Off Necrosis). Patients will be randomized to either FCSEMS or plastic stents for EUS-guided drainage of WON in a 1:1 manner. Following EUS-guided drainage patients in both groups will be assessed pre- procedure, pre -discharge, weeks 1, 6 and months 3, 6, 12 and 24 months. Information will also be collected from any subsequent hospital admissions related to their walled-off necrosis.
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