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

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.

Randomization, as detailed below, is stratified by etiology of the stricture: chronic 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