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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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same as brief summary

Conditions

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Choledocholithiasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Incomplete biliary stone extraction.

ERCP with metal stent

Intervention Type PROCEDURE

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

Interventions

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ERCP with metal stent

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

Intervention Type PROCEDURE

Other Intervention Names

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see above information

Eligibility Criteria

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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.