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

This study has been completed.
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Gregory A. Cote, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01221311
First received: October 8, 2010
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Common Bile Duct Stricture Device: Fully covered Metallic Stent Device: Plastic Stent

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Use of Fully-covered, Self-expandable Metallic Stents for First-line Treatment of Benign Bile Duct Strictures

Further study details as provided by Gregory A. Cote, Medical University of South Carolina:

Primary Outcome Measures:
  • 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.


Enrollment: 112
Study Start Date: January 2011
Study Completion Date: October 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fully Covered Metallic Stent
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.
Device: Fully covered Metallic Stent
Covered Wallflex Biliary (TM)
Active Comparator: Plastic Stent
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).
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.
Other Name: Polyethylene Stent

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221311

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63108
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Digestive Health Associates of Texas
Dallas, Texas, United States
United Kingdom
Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom
Sponsors and Collaborators
Medical University of South Carolina
American Society for Gastrointestinal Endoscopy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Gregory A Cote, MD, MS Medical University of South Carolina
  More Information

Publications:
Responsible Party: Gregory A. Cote, Associate Professor of Medicine, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01221311     History of Changes
Obsolete Identifiers: NCT01432808
Other Study ID Numbers: G100118
R21DK090708 ( US NIH Grant/Contract Award Number )
Study First Received: October 8, 2010
Results First Received: March 21, 2017
Last Updated: May 2, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Gregory A. Cote, Medical University of South Carolina:
stenosis
bile duct
chronic pancreatitis
postoperative
post-liver transplant

Additional relevant MeSH terms:
Constriction, Pathologic
Cholestasis
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 23, 2017