Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent
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|ClinicalTrials.gov Identifier: NCT01239056|
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : August 21, 2015
Last Update Posted : September 7, 2015
|Condition or disease||Intervention/treatment|
|Pancreatic Pseudocysts||Procedure: Endoscopy|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|Official Title:||Prospective Evaluation of the Clinical Utility of Pseudocyst Drainage With Metal Stent|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
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.
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239056
|United States, Florida|
|Shands UF Endoscopy|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Peter V draganov, MD||University of Florida|