Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent

August 21, 2015 updated by: University of Florida

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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.
baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • Pancreatic Pseudocyst

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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