Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent

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

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

Study Overview

• Status: Completed
• Conditions: Pancreatic Pseudocysts
• Intervention / Treatment: Procedure: Endoscopy

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Shands UF Endoscopy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	1 year
Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).	6 to 12 weeks after baseline

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: November 5, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 11, 2010

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: August 21, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Cysts; Pancreatic Diseases; Pancreatic Cyst; Pancreatic Pseudocyst
• Other Study ID Numbers: Pancreatic Pseudocyst