Prospective Evaluation of the Clinical Utility of Pseudocyst Drainage With Metal Stent
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Pseudocysts
- Sponsor
- University of Florida
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is 18 years or older
- •Subject has pancreatic pseudocyst
- •Subject has medical indication for drainage of the pancreatic pseudocyst
- •Subject must be able to give informed consent
Exclusion Criteria
- •Any contraindication to endoscopic pseudocyst drainage
- •Subject is unable to give informed consent
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).(6 to 12 weeks after baseline)
- Adverse Events(1 year)