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

Withdrawn

• Conditions: Choledocholithiasis
• Interventions: Procedure: ERCP with metal stent

• Registration Number: NCT01475864
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

same as brief summary

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-21
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-26
• Last Update Posted: 2013-06-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Incomplete biliary stone extraction.	ERCP with metal stent	-

Primary Outcome Measures

Name	Time	Method
complete biliary stone clearance	12 months	This is an observational study where the ERCP being done is part of the standard of care for choledocholithiasis. There are no study interventions

Secondary Outcome Measures

Name	Time	Method
other techniques used for stone clearance	12 months	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