Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Prospective Evaluation of the Clinical Utility of Pseudocyst Drainage With Metal Stent|
- 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 ] [ Designated as safety issue: No ]
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.
- Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS). [ Time Frame: 6 to 12 weeks after baseline ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
All adult patients who have a clinical indication to undergo an endoscopic drainage of a pancreatic pseudocyst.
Endoscopic drainage of a pancreatic pseudocyst using a metal stent per medical indication.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239056
|United States, Florida|
|Shands UF Endoscopy|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Peter V draganov, MD||University of Florida|