Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent

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

Completed

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Key information

Conditions

Pancreatic Pseudocysts Cysts Digestive System Diseases Neoplasms Pancreatic Cyst Pancreatic Diseases Pancreatic Pseudocyst

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shands UF Endoscopy

Gainesville, Florida, 32608, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Any contraindication to endoscopic pseudocyst drainage
Subject is unable to give informed consent

Treatment and study plan

endoscopy

Procedure

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

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

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.

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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2015
First posted: Nov 11, 2010
Registry last updated: Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed