Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent

University of Florida22 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Pseudocysts

Interventions

EndoscopyPROCEDURE

Endoscopic drainage of a pancreatic pseudocyst using a metal stent per medical indication.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shands UF Endoscopy

Gainesville, Florida, United States

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

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.

Time frame: baseline

Secondary Outcomes

Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).

Time frame: 6 to 12 weeks after baseline

Adverse Events

Time frame: 1 year

Data from ClinicalTrials.gov

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