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

University of Florida

Status: Withdrawn

Conditions: Choledocholithiasis

Treatments: Procedure: ERCP with metal stent

Study type: Observational

Funder types: Other

Identifiers

NCT01475864

Biliary stone

Details and patient eligibility

About

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.

Full description

same as brief summary

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Incomplete biliary stone extraction.

Treatment:

Procedure: ERCP with metal stent