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

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.

Study Overview

• Status: Withdrawn
• Conditions: Choledocholithiasis
• Intervention / Treatment: Procedure: ERCP with metal stent

Detailed Description

same as brief summary

• Study Type: Observational

Participation Criteria

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

Those patients who have a biliary stone that has not been removed by standard medical care.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Incomplete biliary stone extraction.	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; Other Names: see above information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (ESTIMATE): November 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 27, 2013
• Last Update Submitted That Met QC Criteria: June 26, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Choledocholithiasis; metal stents; biliary duct stent
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Choledocholithiasis
• Other Study ID Numbers: Biliary stone