Comparison of FCSEMS and Plastic Stents — WON-MVP  

Acute Pancreatic Fluid Collection Clinical Trial

Official title: Randomized Trial Comparing Fully Covered, Self-Expanding Metal Stent and Plastic Stents for Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis

Status Completed

Clinical Trial Summary

The research design is a randomized prospective clinical trial comparing Endoscopic ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.

Clinical Trial Description

The research design is a randomized prospective clinical trial comparing EUS-guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.The sample size estimated for this study is 60 patients. All patients will undergo EUS-guided drainage of WON and be randomized to either FCSEM or plastic stents in a 1:1 ratio using a computer-generated randomized sequence. It will not be possible to blind the endoscopist to the stent type being inserted due to the differences in stent appearance. The statistician will be blinded to the stent type utilized. ;

Related Conditions & MeSH terms

• Acute Pancreatic Fluid Collection
• Infected Pancreatic Necrosis
• Necrosis
• Pancreatic and Peripancreatic Necrosis
• Pancreatic Collection
• Symptomatic Pancreatic Necrosis

• NCT number: NCT02685865
• Study type: Interventional
• Source: Florida Hospital
• Status: Completed
• Phase: N/A
• Start date: February 12, 2016
• Completion date: August 2018