Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent
Completed
- Conditions
- Pancreatic Pseudocysts
- Interventions
- Procedure: Endoscopy
- Registration Number
- NCT01239056
- Lead Sponsor
- University of Florida
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pancreatic Pseudocysts Endoscopy All adult patients who have a clinical indication to undergo an endoscopic drainage of a pancreatic pseudocyst.
- Primary Outcome Measures
Name Time Method 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 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 Outcome Measures
Name Time Method Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS). 6 to 12 weeks after baseline Adverse Events 1 year
Trial Locations
- Locations (1)
Shands UF Endoscopy
🇺🇸Gainesville, Florida, United States