Chest · 2025
Medical Thoracoscopy With vs Without Prior Artificial Pneumothorax for Patients With Minimal or Absent Pleural Effusion.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Wang Kaige, Zhou Liang, Zhu Min, Zhang Wei, He Zhengguang, Tan Xiaowu, Luo Xing, Min Lingfeng, Xu Feng, Zeng Jun, Qin Hao, Wang Jun, Liu Huizhen, Liu Dan, Tian Panwen, Richeldi Luca, Li Weimin, Luo Fengming
Аннотация
BACKGROUND: Thoracoscopy guidelines recommend inducing artificial pneumothorax before medical thoracoscopy in patients with minimal or absent pleural effusion. Single-arm studies have demonstrated that nonartificial pneumothorax approaches reduce operative time and complication rates compared with artificial pneumothorax techniques in these patients. However, there is a lack of trials comparing the effectiveness and safety of performing artificial pneumothorax vs not performing it in these cases.
RESEARCH QUESTION: For patients with minimal or absent pleural effusion, is nonartificial pneumothorax (non-AP) noninferior to artificial pneumothorax (AP) in terms of the pleural access success rate?
STUDY DESIGN AND METHODS: In this multicenter randomized noninferiority trial, patients with minimal or absent pleural effusion requiring medical thoracoscopy were randomized 1:1 to either an AP group or a non-AP group. The primary outcome was the pleural access success rate, with a noninferiority margin of -10% (non-AP group minus AP group). Secondary outcomes included pathological confirmation rates, complication rates, operation length, air leak duration, drain removal time, chest pain scores, and 90-d mortality.
RESULTS: A total of 204 participants were equally allocated to the AP group (n = 102) and the non-AP group (n = 102). The pleural access success rate was 95.0% in the non-AP group and 78.4% in the AP group (difference, 16.6% [one-sided lower 97.5% CI, 7.6%]; P < .001 for noninferiority). Complications occurred in 14.9% of non-AP patients and 17.6% of AP patients (difference, 2.7% [95% CI, -12.9% to 7.3%]; P = 0.589).
INTERPRETATION: For patients with minimal or absent pleural effusion, artificial pneumothorax is not necessary before performing medical thoracoscopy.
CLINICAL TRIAL REGISTRATION: This study has been prospectively registered in the Chinese Clinical Trial Register, No. ChiCTR2000038708.
RESEARCH QUESTION: For patients with minimal or absent pleural effusion, is nonartificial pneumothorax (non-AP) noninferior to artificial pneumothorax (AP) in terms of the pleural access success rate?
STUDY DESIGN AND METHODS: In this multicenter randomized noninferiority trial, patients with minimal or absent pleural effusion requiring medical thoracoscopy were randomized 1:1 to either an AP group or a non-AP group. The primary outcome was the pleural access success rate, with a noninferiority margin of -10% (non-AP group minus AP group). Secondary outcomes included pathological confirmation rates, complication rates, operation length, air leak duration, drain removal time, chest pain scores, and 90-d mortality.
RESULTS: A total of 204 participants were equally allocated to the AP group (n = 102) and the non-AP group (n = 102). The pleural access success rate was 95.0% in the non-AP group and 78.4% in the AP group (difference, 16.6% [one-sided lower 97.5% CI, 7.6%]; P < .001 for noninferiority). Complications occurred in 14.9% of non-AP patients and 17.6% of AP patients (difference, 2.7% [95% CI, -12.9% to 7.3%]; P = 0.589).
INTERPRETATION: For patients with minimal or absent pleural effusion, artificial pneumothorax is not necessary before performing medical thoracoscopy.
CLINICAL TRIAL REGISTRATION: This study has been prospectively registered in the Chinese Clinical Trial Register, No. ChiCTR2000038708.