Prospective Evaluation of the Covered Self-expandable Metal Stents (CSEMS) for Incomplete Biliary Stone Clearance



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:5/27/2013
Start Date:November 2011
End Date:January 2014
Contact:Peter V Draganov, MD
Email:peter.draganov@medicine.ufl.edu
Phone:352-273-9474

Use our guide to learn which trials are right for you!

Prospective Evaluation of the Clinical Utility of Endoscopically-placed Self Expandable Stents


The current standard of care for bile duct stone are endoscopic sphincterotomy and stone
extraction. Placement of plastic stents is an option for incomplete biliary stone
clearance. This study will use the CSEMS in patients with complex biliary stones who failed
stone extraction as they have the advantage of large stent diameter. CSEMS may offer a
temporizing measure that allows more successful subsequent stone clearance. However, their
use in benign condition has been limited especially for biliary stone removal. The purpose
of this study is to determine the feasibility, safety, easy removability, stent-stone
formation rate, and migration rate of CSEMS for complex biliary stones.


same as brief summary

Inclusion Criteria:

- 18 years and older

- Bilary stone unable to be extracted with balloon, basket, large balloon dilation of
the ampulla or mechanical lithotripsy.

- Stone can be bridged by the metal stent

- Subject must be able to give informed consent.

Exclusion Criteria:

- Any contraindication to ERCP

- Patient refuses consent for the study.
We found this trial at
1
site
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
Click here to add this to my saved trials