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

Choledocholithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01475864
• Other study ID #: Biliary stone
• Status: Withdrawn
• Phase: N/A
• First received: November 16, 2011
• Last updated: June 26, 2013
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

same as brief summary

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Choledocholithiasis

Intervention

Procedure:
• ERCP with metal stent
ERCP will be used so that a metal stent can be placed to facilitate the removal of the biliary stone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete biliary stone clearance	This is an observational study where the ERCP being done is part of the standard of care for choledocholithiasis. There are no study interventions	12 months	No
Secondary	other techniques used for stone clearance	This will include the number of ERCP's needed to achive the complete biliary stone clearance, Use of mechanical Lithotripsy, use of cholangioscopy, procedure duration and any adverse events safety	12 months	No