NCT01221311

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Common Bile Duct Stricture

Interventions

Type	Name	Description
DEVICE	Fully covered Metallic Stent	Covered Wallflex Biliary (TM)
DEVICE	Plastic Stent	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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-10-01
• Completion: 2016-10-01
• First posted: 2010-10-15
• Last updated: 2017-06-02
• Results posted: 2017-05-01

Locations

8 sites across 2 countries: United States, United Kingdom