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

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ClinicalTrials.gov Identifier: NCT01238900
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : October 2, 2015
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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 or disease Intervention/treatment
Benign Biliary Strictures Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

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.

Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical Utility of Placement of Metal Stent for Benign Biliary Strictures
Study Start Date : May 2009
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.

  2. 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).

  3. 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



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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

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

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 Posted: November 11, 2010    Key Record Dates
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