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

Common Bile Duct Stricture Clinical Trial

Official title: Use of Fully-covered, Self-expandable Metallic Stents for First-line Treatment of Benign Bile Duct Strictures

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Bile Duct Stricture
• Constriction, Pathologic

• NCT number: NCT01221311
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2011
• Completion date: October 2016