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NCT Number: NCT01221311

Covered 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.

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Key information

Conditions

Common Bile Duct Stricture Chronic Disease Constriction, Pathologic Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fully covered Metallic Stent

Device

Covered Wallflex Biliary (TM)

Plastic Stent

Device

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.

Other names: Polyethylene Stent

Primary outcomes

  1. Early Clinical Success

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

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • American Society for Gastrointestinal Endoscopy
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Oct 15, 2010
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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