NCT02685865

Comparison of FCSEMS and Plastic Stents

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	FCSEM Stent	Hot Axios Fully covered self-expandable metal stent - Boston Scientific
DEVICE	Plastic Stent	7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific

Timeline

• Start date: 2016-02-12
• Primary completion: 2018-07-10
• Completion: 2018-08-01
• First posted: 2016-02-19
• Last updated: 2019-02-11

Locations

2 sites across 1 country: United States