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Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01239056
First received: November 5, 2010
Last updated: August 21, 2015
Last verified: August 2015
  Purpose
The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.

Condition Intervention
Pancreatic Pseudocysts
Procedure: Endoscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical Utility of Pseudocyst Drainage With Metal Stent

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: August 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pancreatic Pseudocysts
All adult patients who have a clinical indication to undergo an endoscopic drainage of a pancreatic pseudocyst.
Procedure: Endoscopy
Endoscopic drainage of a pancreatic pseudocyst using a metal stent per medical indication.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have a medical indication for endoscopic drainage of pancreatic pseudocyst and are referred for the procedure as part of their standard medical care will be considered for the study.
Criteria

Inclusion Criteria:

  1. Subject is 18 years or older
  2. Subject has pancreatic pseudocyst
  3. Subject has medical indication for drainage of the pancreatic pseudocyst
  4. Subject must be able to give informed consent

Exclusion Criteria:

  1. Any contraindication to endoscopic pseudocyst drainage
  2. Subject is unable to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239056

Locations
United States, Florida
Shands UF Endoscopy
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter V draganov, MD University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01239056     History of Changes
Other Study ID Numbers: Pancreatic Pseudocyst 
Study First Received: November 5, 2010
Results First Received: July 24, 2015
Last Updated: August 21, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Pseudocyst
Pancreatic Cyst
Cysts
Neoplasms
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on December 08, 2016