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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Evaluation of the Clinical Utility of Placement of Metal Stent for Benign Biliary Strictures

Conditions
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Benign Biliary Strictures

Intervention / Treatment
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* Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| benign biliary strictures<br>All patients who have a medical indication for an ERCP to place a stent in their benign biliary strictures | Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)<br>* Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Term Success Rate in the Resolution of Biliary Strictures | 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. | 6 months | 
| Long-term Success Rate in Resolution of Biliary Strictures | 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. | at least 12 months after stent removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Endoscopic Treatments Per Patient | The average number of ERCPs performed per patient required for resolution of benign strictures. | At time of procedure | 
| Ease of Stent Removal | The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed). | at time of procedure | 
| Frequency and Severity of Adverse Events (Including Stent Migration) | Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria | up to 12 months |