Prospective Evaluation of the Covered Self-expandable Metal Stents (CSEMS) for Incomplete Biliary Stone Clearance
This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01475864
First received: November 16, 2011
Last updated: March 13, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Choledocholithiasis |
Procedure: ERCP with metal stent |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Prospective Evaluation of the Clinical Utility of Endoscopically-placed Self Expandable Stents |
Resource links provided by NLM:
Further study details as provided by University of Florida:
Primary Outcome Measures:
- complete biliary stone clearance [ Time Frame: 12 months ] [ Designated as safety issue: No ]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:
- other techniques used for stone clearance [ Time Frame: 12 months ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Incomplete biliary stone extraction. |
Procedure: ERCP with metal stent
ERCP will be used so that a metal stent can be placed to facilitate the removal of the biliary stone
Other Name: see above information
|
Detailed Description:
same as brief summary
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Those patients who have a biliary stone that has not been removed by standard medical care.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475864
Contacts
| Contact: Peter V Draganov, MD | 352-273-9474 | peter.draganov@medicine.ufl.edu |
Locations
| United States, Florida | |
| University of Florida/Shands | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Peter V Draganov, MD 352-273-9400 peter.draganov@medicine.ufl.edu | |
| Principal Investigator: Peter V Draganov, MD | |
Sponsors and Collaborators
University of Florida
Investigators
| Principal Investigator: | Peter V Draganov, MD | University of Florida |
More Information
No publications provided
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01475864 History of Changes |
| Other Study ID Numbers: | Biliary stone |
| Study First Received: | November 16, 2011 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Florida:
|
Choledocholithiasis metal stents biliary duct stent |
Additional relevant MeSH terms:
|
Choledocholithiasis Common Bile Duct Diseases Bile Duct Diseases |
Biliary Tract Diseases Digestive System Diseases Cholelithiasis |
ClinicalTrials.gov processed this record on May 19, 2013