Prospective Evaluation of the Clinical Utility of Placement of Metal Stent for Benign Biliary Strictures
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Benign Biliary Strictures
- Sponsor
- University of Florida
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Short Term Success Rate in the Resolution of Biliary Strictures
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is 18 years or older
- •Subject has benign biliary stricture
- •Subject must be able to give informed consent
Exclusion Criteria
- •Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
- •The subject is unable to give informed consent
Outcomes
Primary Outcomes
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 Outcomes
- Ease of Stent Removal(at time of procedure)
- Frequency and Severity of Adverse Events (Including Stent Migration)(up to 12 months)
- Number of Endoscopic Treatments Per Patient(At time of procedure)