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

NCT01475864 | Withdrawn

• 1 other identifier: Biliary stone
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Choledocholithiasis

Keywords

Choledocholithiasis; metal stents; biliary duct stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• other techniques used for stone clearance

  12 months

Study Arms (1)

Incomplete biliary stone extraction.

Procedure: ERCP with metal stent

Interventions

ERCP with metal stent PROCEDURE

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

Also known as: see above information

Incomplete biliary stone extraction.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Any contraindication to ERCP
• Patient refuses consent for the study.

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Peter V Draganov, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 27, 2013

Record last verified: 2013-06