Objective
To compare the effectiveness of three treatments for idiopathic subglottic stenosis (iSGS) on delaying time to recurrence and improving patient-reported outcomes
Study Design
| Design Elements |
Description |
| Design |
Observational: cohort study |
| Population |
810 patients with iSGS |
Interventions/
Comparators |
- Endoscopic dilation
- Endoscopic resection with long-term medical therapy
- Open cricotracheal resection
|
| Outcomes |
Primary: time to recurrence
Secondary: breathing, speaking, and swallowing ability; global quality of life
|
| Timeframe |
3-year follow-up for primary outcome |
iSGS is a rare illness in which the trachea narrows for no known reason. The illness is recurrent and can cause severe difficulties with breathing, speaking, and swallowing. iSGS most commonly affects white women. This prospective cohort study compared the effectiveness of three common treatments for iSGS on time to recurrence, or how long after the procedure it takes for patients to experience recurrent stenosis and the need to undergo repeat surgical treatment.
Patients underwent one of three initial treatments for iSGS:
- Endoscopic dilation. Doctors access the patient’s trachea through the mouth and dilate, or stretch, the narrowed portion of the airway using surgical instruments or inflatable balloons.
- Endoscopic resection with long-term medical therapy. Doctors access the patient’s trachea through the mouth and use a surgical laser to resect a portion of the airway scar. After this procedure, patients require long-term medication use.
- Open cricotracheal resection. Doctors use an external incision to remove the damaged section of trachea and reconstruct the airway.
This study included 810 patients from 40 clinics in the United States, Australia, France, Iceland, Norway, and the United Kingdom. Of these patients, 97% were white, 98% were female, and the median age was 50. Prior to the study, patients had no history of surgical treatment for iSGS.
Throughout three years, patients were followed every three months to determine if they needed another surgical procedure. Every six months, researchers administered surveys to patients about their iSGS symptoms to compare their breathing, speaking, and swallowing and overall quality of life. These outcomes were assessed up to one year following treatment.
Patients with iSGS, iSGS providers, and regional patient advocates worked with researchers to plan and conduct the study, recruit participants, and distribute study results.
Results
Within the three-year timeframe, 185 patients, or 23%, required a subsequent procedure (mean follow-up 1.4 years). Open tracheal resection had the lowest recurrence rate (1%), followed by endoscopic resection (12%) and endoscopic dilation (28%). Differences across recurrence rates were significant (all p<0.01) and clinically important.
At one year patients who received endoscopic dilation reported worse breathing ability (p<0.001) and poorer quality of life (p=0.015) than patients who received the other two treatments. Patients who received open cricotracheal resection reported worse speaking ability than patients receiving the other two treatments (p<0.001). Patient-reported swallowing ability did not differ across the three treatments.
Limitations
Lack of a randomized study design limits the ability to draw conclusions from the study results. For example, surgeons may be better trained in one treatment than another, which could have influenced outcomes rather than the type of treatment itself.
Conclusions and Relevance
In this study, open cricotracheal resection had the lowest rate of iSGS recurrence but was associated with worse speaking ability. Endoscopic resection with long-term medical therapy had a lower recurrence rate than endoscopic dilation, with less impact on speaking ability than open tracheal resection.
Future Research Needs
Future research could follow patients for longer than three years to determine if the relative effectiveness of the three treatments changes over time.
