VIOLET (video-assisted thoracoscopic surgery)
Trial question
Is video-assisted thoracoscopic surgery superior to open surgery in patients with early-stage lung cancer?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
50.0% female
50.0% male
N = 502
502 patients (253 female, 249 male).
Inclusion criteria: patients with early-stage lung cancer.
Key exclusion criteria: previous malignancy influencing life expectancy; planned pneumonectomy or non-anatomic resection; serious concomitant disorder compromising patient safety during surgery; planned robotic surgery.
Interventions
N=247 VATS lobectomy (video-assisted thoracoscopic surgery).
N=255 open lobectomy (conventional open surgery).
Primary outcome
Improvement in physical function at week 28
73
67
73.0
54.8
36.5
18.3
0.0
VATS
lobectomy
Open
lobectomy
Significant
increase ▲
Significantly greater improvement in physical function at week 28 (73 vs. 67; MD 4.65, 95% CI 1.69 to 7.61).
Secondary outcomes
Significant decrease in pain score at day 2 post-op (3 points vs. 4 points; MD -0.54, 95% CI -0.99 to -0.09).
Safety outcomes
No significant difference in serious adverse events in hospital.
Significant differences in adverse events in hospital (32.8% vs. 44.3%), serious adverse events after discharge (30.7% vs. 37.8%).
Conclusion
In patients with early-stage lung cancer, VATS lobectomy was superior to open lobectomy with respect to improvement in physical function at week 28.
Reference
Eric Lim, Tim J P Batchelor, Joel Dunning et al. Video-Assisted Thoracoscopic or Open Lobectomy in Early-Stage Lung Cancer. NEJM Evid. 2022 Mar;1(3):EVIDoa2100016.
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