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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Common Bile Duct Stricture

Treatments: Device: Plastic Stent; Device: Fully covered Metallic Stent

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01221311

R21DK090708 (U.S. NIH Grant/Contract)

G100118

Details and patient eligibility

About

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.

Full description

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

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Fully Covered Metallic Stent

Experimental group

Description:

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.

Treatment:

Device: Fully covered Metallic Stent

Plastic Stent

Active Comparator group

Description:

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).

Treatment:

Device: Plastic Stent