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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:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01238900
First received: November 5, 2010
Last updated: August 31, 2015
Last verified: August 2015
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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| 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:
- 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238900
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | November 5, 2010 |
| Results First Received: | June 29, 2015 |
| Last Updated: | August 31, 2015 |
Additional relevant MeSH terms:
|
Constriction, Pathologic Cholestasis Pathological Conditions, Anatomical |
Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on August 18, 2017