Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1239 participants
OBSERVATIONAL
2015-08-28
2020-09-10
Brief Summary
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With the results of this trial, the investigators hope to provide information to iSGS patients: (1) Given my personal characteristics, conditions, and preferences, what should I expect will happen to me? and (2) What are my options, and what are the potential benefits and harms of these options?
Detailed Description
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People with this disease often require several surgeries per year. A variety of treatments have been advanced to manage iSGS but are generally categorized into: 1) endoscopic dilation of the tracheal stenosis (accomplished with rigid instruments or inflatable balloons); 2) endoscopic resection of the stenosis (with prolonged medical therapy after surgery); or 3) open neck surgery with resection of the affected tracheal segment with end-to-end anastomosis. Each patient can require repeated surgeries to keep their trachea open, which increases odds of treatment side effects and complications. All approaches have unique and often disabling associated side effects, which can significantly affect a patient's quality of life.
Because the disease is rare, it is difficult for patients to find good information so that they can understand the spectrum of treatment options. This is particularly difficult because most patients present with severe breathing trouble and need treatment quickly, limiting their ability to explore options. Additionally, there is a general lack of high-quality, reliable, and accessible data to inform individual patient decision-making. Imperfect information and limited evidence on treatment outcomes complicate patient decision-making as they try to balance survival, symptoms, and quality of life considerations.
Beyond the gaps in understanding the relative effectiveness of the different treatments available, no studies have explored functional outcomes in iSGS (i.e. how well patients breathe, speak, and swallow after treatments). These endpoints are important to patients and are arguably a primary determinant in decision-making. Direct engagement with patients is critical to understand these quality of life considerations, since patient and physician perspectives aren't always the same. For example, results show that endoscopic dilation is associated with a higher rate of disease recurrence and thus need for repeated surgery. Meanwhile, open tracheal resection is a major surgery with significant immediate perioperative risks and has been associated with alterations in voice and swallowing. Open tracheal resection appears to reduce the risk of disease recurrence, but the degree of benefit, and the trade-offs associated with this approach are unanswered questions.
The proposed study from the North American Airway Collaborative (NoAAC PR- 02) is designed to fill this void. Our prospective study will directly compare the effectiveness of standard of care treatments and assess their associated quality of life tradeoffs in iSGS patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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iSGS patients
Participants will receive standard of care treatment at the respective center and will be followed longitudinally for symptom changes, need for further treatment, complications, and will have Patient-reported outcomes (PROs) administered at a priori determined intervals.
Endoscopic dilation of subglottic stenosis
This is accomplished with rigid instruments or inflatable balloons.
Endoscopic resection of the stenosis
This is accomplished with C02 lasers and paired with prolonged medical therapy after surgery.
Tracheal Resection
Resection of the affected tracheal segment with end-to-end anastomosis
Interventions
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Endoscopic dilation of subglottic stenosis
This is accomplished with rigid instruments or inflatable balloons.
Endoscopic resection of the stenosis
This is accomplished with C02 lasers and paired with prolonged medical therapy after surgery.
Tracheal Resection
Resection of the affected tracheal segment with end-to-end anastomosis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The lesion must involve the subglottis.
Exclusion Criteria
* Patients without capacity to consent for themselves
* History of significant laryngotracheal traumatic injury.
* History of endotracheal intubation or tracheotomy within 2 years of presentation.
* Major anterior neck surgery.
* History of neck irradiation.
* History of caustic or thermal injuries to the laryngotracheal complex.
* History of a clinically diagnosed vasculitis or collage vascular disease.
* Positive antinuclear cytoplasmic antibody titers.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
The Cleveland Clinic
OTHER
University of Utah
OTHER
Johns Hopkins University
OTHER
Vanderbilt University
OTHER
University of Virginia
OTHER
Massachusetts Eye and Ear Infirmary
OTHER
Oregon Health and Science University
OTHER
University of Washington
OTHER
University of California, San Francisco
OTHER
University of California, Los Angeles
OTHER
University of California, San Diego
OTHER
University of Colorado, Denver
OTHER
Baylor College of Medicine
OTHER
Louisiana State University Health Sciences Center in New Orleans
OTHER
Charing Cross Hospital
OTHER
University of Alabama at Birmingham
OTHER
University of Wisconsin, Madison
OTHER
University of Michigan
OTHER
University of Nebraska
OTHER
University of Iowa
OTHER
University of Texas
OTHER
Duke University
OTHER
University of North Carolina
OTHER
Augusta University
OTHER
University of Sydney
OTHER
North American Airway Collaborative
UNKNOWN
University of California, Irvine
OTHER
University of Pittsburgh
OTHER
Loma Linda University
OTHER
Stanford University
OTHER
University of Cincinnati
OTHER
Emory University
OTHER
Ohio State University
OTHER
University of Southern California
OTHER
Temple University
OTHER
Medical College of Wisconsin
OTHER
Landspitali University Hospital
OTHER
Bastian Voice Institute
UNKNOWN
NYU Langone Health
OTHER
Mayo Clinic
OTHER
University of Miami
OTHER
University of Rochester
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
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Alexander Gelbard, MD
Assistant Professor, Department of Otolaryngology
Principal Investigators
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Alexander Gelbard, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
David O. Francis, MD, MS
Role: STUDY_CHAIR
Vanderbilt University Medical Center
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
University of California Irvine
Irvine, California, United States
Loma Linda University Health Care
Loma Linda, California, United States
University of Southern California
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Bastian Voice Institute
Downers Grove, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Louisiana State University
Baton Rouge, Louisiana, United States
Johns Hopkins
Baltimore, Maryland, United States
Harvard Medical School -Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska
Omaha, Nebraska, United States
New York University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
University of Cincinatti
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
University of Sydney
St Leonards, , Australia
Landspitali University Hospital
Reykjavik, , Iceland
Charing Cross Hospital, Imperial College London
London, , United Kingdom
Countries
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References
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Gelbard A, Shyr Y, Berry L, Hillel AT, Ekbom DC, Edell ES, Kasperbauer JL, Lott DG, Donovan DT, Garrett CG, Sandhu G, Daniero JJ, Netterville JL, Schindler JS, Smith ME, Bryson PC, Lorenz RR, Francis DO. Treatment options in idiopathic subglottic stenosis: protocol for a prospective international multicentre pragmatic trial. BMJ Open. 2018 Apr 10;8(4):e022243. doi: 10.1136/bmjopen-2018-022243.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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150917
Identifier Type: -
Identifier Source: org_study_id