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

Completed · Not applicable

Conditions studied: Common Bile Duct Stricture

In brief

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.

Key facts

Study ID

NCT01221311

Run by

Medical University of South Carolina

People needed

112

Starts

2011-01-01

Expected to finish

2016-10-01

Last updated by the study team

2017-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Bismuth Type I benign bile duct stricture
• Objective signs/symptoms related to the stricture

You may not qualify if…

• 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

Where it is running

• University of Chicago — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Digestive Health Associates of Texas — Dallas, Texas, United States
• Royal Wolverhampton NHS Trust — Wolverhampton, United Kingdom

Full record on ClinicalTrials.gov

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