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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238900
First Posted: November 11, 2010
Last Update Posted: October 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  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:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Short Term Success Rate in the Resolution of Biliary Strictures [ Time Frame: 6 months ]
    Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.

  • Long-term Success Rate in Resolution of Biliary Strictures [ Time Frame: at least 12 months after stent removal ]
    Long-term success was defined as no clinical evidence of recurrence of the biliary stricture during the follow-up period as documented by laboratory findings or imaging and no further need for further endoscopic or surgical interventions.


Secondary Outcome Measures:
  • Number of Endoscopic Treatments Per Patient [ Time Frame: At time of procedure ]
    The average number of ERCPs performed per patient required for resolution of benign strictures.

  • Ease of Stent Removal [ Time Frame: at time of procedure ]
    The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed).

  • Frequency and Severity of Adverse Events (Including Stent Migration) [ Time Frame: up to 12 months ]
    Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria


Enrollment: 23
Study Start Date: May 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
benign biliary strictures
All patients who have a medical indication for an ERCP to place a stent in their benign biliary strictures
Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)
Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct

Detailed Description:
In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data is sparse. This study was performed to evaluate the long -term effectiveness and safety of a new fully covered SEMS for benign biliary strictures.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238900


Locations
United States, Florida
Shands at UF endoscopy center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter Draganov, MD University of Florida
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01238900     History of Changes
Other Study ID Numbers: Benign Biliary Strictures
First Submitted: November 5, 2010
First Posted: November 11, 2010
Results First Submitted: June 29, 2015
Results First Posted: October 2, 2015
Last Update Posted: October 2, 2015
Last Verified: August 2015

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