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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01475864

Enrollment

Registered

2011-11-21

Start date

2011-11-30

Completion date

2013-06-30

Last updated

2013-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis

Keywords

Choledocholithiasis, metal stents, biliary duct stent

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

Interventions

PROCEDUREERCP with metal stent

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026