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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Indiana University
Sponsor:
Collaborator:
American Society for Gastrointestinal Endoscopy
Information provided by (Responsible Party):
Gregory A. Cote, Indiana University
ClinicalTrials.gov Identifier:
NCT01221311
First received: October 8, 2010
Last updated: April 9, 2013
Last verified: April 2013
  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
Benign Bile Duct Strictures
Device: Fully covered Metallic Stent
Device: Plastic Stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Fully-covered, Self-expandable Metallic Stents for First-line Treatment of Benign Bile Duct Strictures

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Late Clinical Success [ Time Frame: Up to two years after enrollment ] [ Designated as safety issue: No ]
    Late clinical success will be defined as fluoroscopic resolution at the time of final stent(s) withdrawal as well as the absence of objective findings of stricture recurrence during the one year, post-stenting follow-up period.


Secondary Outcome Measures:
  • Technical success [ Time Frame: After each procedure, procedures are performed every 3 months for up to one year ] [ Designated as safety issue: Yes ]
    Technical success will be defined as the completion of the initial and each follow-up ERCP, including stent deployment and removal. Cases where stents cannot be deployed or removed via endoscopy will be considered technical failures. We will compare technical success rates in each group.

  • Early clinical success [ Time Frame: Post-stent removal (up to one year after enrollment) ] [ Designated as safety issue: No ]
    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.

  • Cost analysis [ Time Frame: One year post-stent removal (up to two years after enrollment) ] [ Designated as safety issue: No ]
    For patients at the coordinating center, costs will be measured from multiple sources. The primary source of direct costs associated with cSEMS and PS is from the billing department of the local health system, which has agreed to provide us with the paid charges for our enrolled patients for two years from the first ERCP. We will include all care directly related to the stricture, including inpatient hospitalizations for the management of complications.

  • Complication rates [ Time Frame: Throughout study period (up to two years after enrollment) ] [ Designated as safety issue: Yes ]
    Complication rates will be assessed by the number of procedure-related complications, including post-ERCP pancreatitis, bowel perforation, gastrointestinal bleeding, stent-associated stricture/change (see below) and stent migration. In addition, the endoscopic removability of the cSEMS will be recorded. Complications will be classified as major or minor. A major complication will be defined as any procedure-related complication that requires procedural intervention or hospitalization for > 5 days. All other complications will be classified as minor.

  • Stent-associated ductal changes [ Time Frame: Post-stenting (up to one year after enrollment) ] [ Designated as safety issue: Yes ]
    Physicians with extensive experience in ERCP will review completion cholangiograms that are obtained at the time of final stent withdrawal.


Estimated Enrollment: 250
Study Start Date: January 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fully Covered Metallic Stent
Among patients randomized to the 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 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 (details below).
Device: Plastic Stent
Patients randomized to the PS group will be treated using a standard algorithm (figure 2). 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 (details below).
Other Name: Polyethylene Stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • Bismuth Type II-IV stricture
  • Proximal common hepatic duct diameter < 6 mm
  • Intact gallbladder
  • 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

Contacts
Contact: Laura Lazzell-Pannell, BSN, CCRC 3179483119 llazzell@iupui.edu

Locations
United States, Florida
University of Florida at Gainsville Recruiting
Gainsville, Florida, United States
Contact: Mihir Wagh, MD         
Principal Investigator: Peter Draganov, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States
Contact: Andres Gelrud         
Principal Investigator: Irving Waxman, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Laura Lazzell-Pannell, BS, CCRC    317-948-3119    llazzell@iupui.edu   
Principal Investigator: Gregory A Cote, MD, MS         
United States, Missouri
Washington University in St. Louis Recruiting
St. Louis, Missouri, United States, 63108
Contact: Daniel Mullady, MD       dmullady@dom.wustl.edu   
Principal Investigator: Sreenivasa Jonnalagadda, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Kathleen Bauer, RN, CCRC    412-648-9840    kbauer@pitt.edu   
Principal Investigator: Adam Slivka, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States
Contact: Joseph Romagnuolo, MD, MPH         
Principal Investigator: Joseph Romagnuolo, MD, MPH         
United States, Texas
Digestive Health Associates of Texas Not yet recruiting
Dallas, Texas, United States
Contact: Paul Tarnasky, MD         
Principal Investigator: Paul Tarnasky, MD         
Sponsors and Collaborators
Indiana University
American Society for Gastrointestinal Endoscopy
Investigators
Principal Investigator: Gregory A Cote, MD, MS Indiana University
  More Information

No publications provided

Responsible Party: Gregory A. Cote, Assistant Professor of Clinical Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT01221311     History of Changes
Other Study ID Numbers: G100118
Study First Received: October 8, 2010
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
Benign biliary stricture
Benign bile duct stricture
Chronic pancreatitis
Post-operative
Post-liver transplant

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 01, 2014