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

Medical University of South Carolina112 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Common Bile Duct Stricture

Interventions

Fully covered Metallic StentDEVICE

Covered Wallflex Biliary (TM)

Plastic StentDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Outcomes

Primary Outcomes

Early Clinical Success

Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group.

Time frame: Post-stent removal (up to one year after enrollment)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.