Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
| Status: | Active, not recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2011 |
| End Date: | October 2016 |
Use of Fully-covered, Self-expandable Metallic Stents for First-line Treatment of Benign Bile Duct Strictures
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.
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.
Randomization, as detailed below, is stratified by etiology of the stricture: chronic
pancreatitis and postoperative (such as post-liver transplant).
pancreatitis and postoperative (such as post-liver transplant).
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
We found this trial at
8
sites
University of Chicago One of the world's premier academic and research institutions, the University of...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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