Treatment Alternatives in iSGS (NoAAC PR-02 Study)



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:August 28, 2015
End Date:October 2020

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Treatment Alternatives in Adult Rare Disease; Assessment of Options in Idiopathic Subglottic Stenosis North American Airway Collaborative PR-02 Study (NoAAC PR-02 Study)

The study is aimed at answering the questions; (1) How well do the most commonly used
treatments in iSGS work? and (2) What quality-of-life trade-offs are associated with each
approach?

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?

Idiopathic subglottic stenosis (iSGS) is a rare disease in which the trachea narrows for no
known reason. Although uncommon (with an estimated incidence of 1:400,000 persons per year),
both the disease and its therapies profoundly affect patients' ability to breathe,
communicate and swallow. Breathing difficulties (i.e. dyspnea) is the hallmark symptom and
the primary cause of death and disability. However, patients can also experience debilitating
voice changes and swallowing problems due to the condition or its treatment.

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.

Inclusion Criteria:

- Greater than 18 years of age.

- The lesion must involve the subglottis.

Exclusion Criteria:

- Less than 18 years of age

- 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.
We found this trial at
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Dinesh Chhetri, M.D.
Phone: 310-206-6688
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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Durham, North Carolina 27710
(919) 684-8111
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1200 Moursund Street
Houston, Texas 77030
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101 Jessup Hall
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(319) 335-3500
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Phone: 800-777-8442
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1211 Medical Center Dr
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60 Crittenden Blvd # 70
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201 Presidents Circle
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500 S State St
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Chapel Hill, North Carolina 27599
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Charlottesville, Virginia 22903
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