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

Primary Purpose

Common Bile Duct Stricture

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Fully covered Metallic Stent
Plastic Stent
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Bile Duct Stricture focused on measuring stenosis, bile duct, chronic pancreatitis, postoperative, post-liver transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago
  • Indiana University
  • University of Michigan
  • Washington University in St. Louis
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina
  • Digestive Health Associates of Texas
  • Royal Wolverhampton NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fully Covered Metallic Stent

Plastic Stent

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 8, 2010
Last Updated
May 2, 2017
Sponsor
Medical University of South Carolina
Collaborators
American Society for Gastrointestinal Endoscopy, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01221311
Brief Title
Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
Official Title
Use of Fully-covered, Self-expandable Metallic Stents for First-line Treatment of Benign Bile Duct Strictures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
American Society for Gastrointestinal Endoscopy, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Stricture
Keywords
stenosis, bile duct, chronic pancreatitis, postoperative, post-liver transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fully Covered Metallic Stent
Arm Type
Experimental
Arm Description
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.
Arm Title
Plastic Stent
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Fully covered Metallic Stent
Intervention Description
Covered Wallflex Biliary (TM)
Intervention Type
Device
Intervention Name(s)
Plastic Stent
Other Intervention Name(s)
Polyethylene Stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Early Clinical Success
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A Cote, MD, MS
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Digestive Health Associates of Texas
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Royal Wolverhampton NHS Trust
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27002446
Citation
Cote GA, Slivka A, Tarnasky P, Mullady DK, Elmunzer BJ, Elta G, Fogel E, Lehman G, McHenry L, Romagnuolo J, Menon S, Siddiqui UD, Watkins J, Lynch S, Denski C, Xu H, Sherman S. Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1250-7. doi: 10.1001/jama.2016.2619.
Results Reference
result

Learn more about this trial

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

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