Skip to main content
Clinical Trials/NCT01239056
NCT01239056
Completed
Not Applicable

Prospective Evaluation of the Clinical Utility of Pseudocyst Drainage With Metal Stent

University of Florida1 site in 1 country22 target enrollmentAugust 2009

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
May 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

Loading locations...

Similar Trials