SPOC
Trial question
What is the role of silicone stent placement in symptomatic airway obstruction due to non-small cell lung cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
18.0% female
82.0% male
N = 78
78 patients (14 female, 64 male).
Inclusion criteria: patients with symptomatic malignant airway obstruction due to inoperable primary non-small cell lung cancer, requiring therapeutic bronchoscopy.
Key exclusion criteria: contraindication for general anesthesia; one lung not working beyond stenosis; under guardianship; pregnancy; unable to participate in a 12-month follow-up.
Interventions
N=40 silicone stenting (insertion of a silicone stent covering the entire tumor area).
N=38 no stenting (no silicone stent insertion).
Primary outcome
Improvement in dyspnea score at 1 year follow-up
4 points
6.3 points
6.3 points
4.7 points
3.1 points
1.6 points
0.0 points
Silicone
stenting
No
stenting
Significant
decrease ▼
Significantly smaller improvement in dyspnea score at 1 year follow-up (4 points vs. 6.3 points; AD -2.3 points, 95% CI -3.94 to -0.66).
Conclusion
In patients with symptomatic malignant airway obstruction due to inoperable primary non-small cell lung cancer, requiring therapeutic bronchoscopy, silicone stenting was superior to no stenting with respect to improvement in dyspnea score at 1 year follow-up.
Reference
Hervé Dutau, Fabrice Di Palma, Yoann Thibout et al. Impact of Silicone Stent Placement in Symptomatic Airway Obstruction due to Non-Small Cell Lung Cancer - A French Multicenter Randomized Controlled Study: The SPOC Trial. Respiration. 2020;99(4):344-352.
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