Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent

Pancreatic Pseudocysts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239056
• Other study ID #: Pancreatic Pseudocyst
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: August 21, 2015
• Start date: August 2009
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatic Pseudocyst
• Pancreatic Pseudocysts

Intervention

Procedure:
• Endoscopy
Endoscopic drainage of a pancreatic pseudocyst using a metal stent per medical indication.

Locations

Country	Name	City	State
United States	Shands UF Endoscopy	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline	No
Secondary	Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).		6 to 12 weeks after baseline	No
Secondary	Adverse Events		1 year	Yes