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Evaluation of the Use of Metal Stents as Part of the Treatment of Benign Biliary Strictures

This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01238900
First received: November 5, 2010
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures.


Condition Intervention
Benign Biliary Strictures
 Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical Utility of Placement of Metal Stent for Benign Biliary Strictures

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Benign Biliary Strictures resolution [ Time Frame: approxiamtely 2-3 hours ] [ Designated as safety issue: No ]
    This is an observational study looking at the effectiveness of using metal stents in the resolution of benign biliary stricture.


Estimated Enrollment: 150
Study Start Date: August 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
benign biliary strictures
All patients who have a medical indication for stenting of their benign biliary strictures
 Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)
Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct

  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

Patients who have a medical indication for endoscopic therapy of benign biliary stictures and are referred for the procedure as part of their standard medical care will be considered for the study.

Criteria

Inclusion Criteria:

  1. Subject is 18 years or older
  2. Subject has benign biliary stricture
  3. Subject must be able to give informed consent

Exclusion Criteria:

  1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
  2. The subject is unable to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238900

Contacts
Contact: Peter Draganov, MD 352-273-9400 peter.draganov@medicine.ufl.edu

Locations
United States, Florida
Shands at UF endoscopy center Recruiting
Gainesville, Florida, United States, 32608
Contact: Peter Draganov, MD     352-273-9400     peter.draganov@medicine.ufl.edu    
Principal Investigator: Peter Draganov, MD            
Sub-Investigator: Chris Forsmark, MD            
Sub-Investigator: Mihir Wagh, MD            
Sub-Investigator: Shailendra Chauhan, MD            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter Draganov, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01238900     History of Changes
Other Study ID Numbers: Benign Biliary Strictures
Study First Received: November 5, 2010
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cholestasis
Constriction, Pathologic
Bile Duct Diseases
 Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013