Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures

Study Overview
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Brief Summary
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The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. This approach necessitates multiple procedures which may extend over one year before the stricture is adequately dilated. The investigators propose a study comparing the standard approach of plastic stenting with the use of newer, fully coated metallic stents which are self-expandable, thereby permitting successful dilation of benign bile duct strictures with fewer procedures.

Detailed Description
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Randomization, as detailed below, is stratified by etiology of the stricture: chronic pancreatitis and postoperative (such as post-liver transplant).

Official Title
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Use of Fully-covered, Self-expandable Metallic Stents for First-line Treatment of Benign Bile Duct Strictures

Conditions
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Common Bile Duct Stricture

Intervention / Treatment
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* Device: Fully covered Metallic Stent
* Device: Plastic Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bismuth Type I benign bile duct stricture Objective signs/symptoms related to the stricture Exclusion Criteria: Suspected malignant etiology for the stricture Prior endotherapy within one year of presentation,except in the following two scenarios: 1) Early (< 30 days) stent placement following liver transplant; 2) in patients with chronic pancreatitis, single plastic stent placed during presenting ERCP while evaluating for malignancy Bismuth Type II-IV stricture Proximal common hepatic duct diameter < 6 mm Intact gallbladder, except in cases where a stent can be deployed > 1cm below the cystic duct insertion Age < 18 years, pregnancy, incarceration, inability to provide informed consent Karnofsky score ≤ 40 Inability to pass a guidewire proximal to the stricture Stricture > 8cm in length Life expectancy < 1 year Concomitant nonanastomotic biliary strictures or biliary casts

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fully Covered Metallic Stent<br>Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist. | Device: Fully covered Metallic Stent<br>* Covered Wallflex Biliary (TM)<br>|
| Active Comparator: Plastic Stent<br>Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below). | Device: Plastic Stent<br>* Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing ERCPs, until the stricture has been obliterated using clinical and fluoroscopic criteria.<br>* Other names: Polyethylene Stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Clinical Success | Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group. | Post-stent removal (up to one year after enrollment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stenosis, bile duct, chronic pancreatitis, postoperative, post-liver transplant