Clinical Trial: Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Prospective Evaluation of the Clinical Utility of Pseudocyst Drainage With Metal Stent
Brief Summary: The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.
Detailed Summary:
Sponsor: University of Florida
Current Primary Outcome: Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen [ Time Frame: baseline ]
Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst .
Technical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst.
Original Primary Outcome: Resolution of Pancreatic Pseudocyst after placement of metal stent. [ Time Frame: Approximately 2-3 hours ]
Current Secondary Outcome:
- Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS). [ Time Frame: 6 to 12 weeks after baseline ]
- Adverse Events [ Time Frame: 1 year ]
Original Secondary Outcome:
Information By: University of Florida
Dates:
Date Received: November 5, 2010
Date Started: August 2009
Date Completion:
Last Updated: August 21, 2015
Last Verified: August 2015
