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

NCT01221311 | Completed Results DMC

• 2 other identifiers: G100118R21DK090708
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 8

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.

Conditions

Common Bile Duct Stricture

Keywords

stenosis; bile duct; chronic pancreatitis; postoperative; post-liver transplant

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Fully Covered Metallic Stent

EXPERIMENTAL

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

Plastic Stent

ACTIVE COMPARATOR

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

Interventions

Fully covered Metallic Stent DEVICE

Covered Wallflex Biliary (TM)

Fully Covered Metallic Stent

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.

Also known as: Polyethylene Stent

Plastic Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bismuth Type I benign bile duct stricture
• Objective signs/symptoms related to the stricture

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• American Society for Gastrointestinal Endoscopy: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (8)

University of Chicago

Chicago, Illinois, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Michigan

Ann Arbor, Michigan, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63108, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Digestive Health Associates of Texas

Dallas, Texas, United States

Location

Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27002446 RESULT

MeSH Terms

Conditions

Constriction, Pathologic; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Gregory Cote
• Organization: Medical University of South Carolin

cotea@musc.edu

843-876-4261

Study Officials

• Gregory A Cote, MD, MS

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 15, 2010
• Study Start: January 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: June 2, 2017
• Results First Posted: May 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); GB (1)