Medical Thoracoscopy With vs Without Prior Artificial Pneumothorax for 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.

单臂研究显示，与人工气胸技术相比，非人工气胸方法在这些患者中减少了手术时间和并发症率。

However, there is a lack of trials comparing the effectiveness and safety of performing artificial pneumothorax vs not performing it in these cases.

然而，目前尚无比较在这些情况下进行人工气胸与不进行人工气胸的有效性和安全性的试验。

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?

对于胸膜积液极少或不存在的患者，非人工气胸（非AP）在胸膜穿刺成功率方面是否不劣于人工气胸（AP）？

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.

在这项多中心随机非劣效试验中，需要医疗胸腔镜的患者，其胸腔积液极少或无，被随机分为AP组和非AP组，比例为1:1。

The primary outcome was the pleural access success rate, with a noninferiority margin of -10% (non-AP group minus AP group).

主要结果是胸腔穿刺成功率达到非劣效边界为-10%（非AP组减去AP组）。

Secondary outcomes included pathological confirmation rates, complication rates, operation length, air leak duration, drain removal time, chest pain scores, and 90-d mortality.

次要结果包括病理确认率、并发症率、手术时长、漏气持续时间、引流管移除时间、胸痛评分以及90天内的死亡率。

Results

A total of 204 participants were equally allocated to the AP group (n = 102) and the non-AP group (n = 102).

共有204名参与者被平均分配到AP组（n = 102）和非AP组（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).

非AP组的胸膜穿刺成功率是95.0%，而AP组为78.4%（差异，16.6% [单侧下限97.5%置信区间，7.6%]；P < .001，表明非劣效性）。

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).

非AP患者中有14.9%出现并发症，而AP患者中有17.6%出现并发症（差异，2.7% [95%置信区间，-12.9%至7.3%]；P = 0.589）。

interpretation

For patients with minimal or absent pleural effusion, artificial pneumothorax is not necessary before performing medical thoracoscopy.

对于胸膜积液轻微或不存在的患者，在进行内科胸腔镜检查前无需进行人工气胸。

clinical_trial_registration

This study has been prospectively registered in the Chinese Clinical Trial Register, No. ChiCTR2000038708.

本研究已在中国临床试验注册中心前瞻性注册，注册号为ChiCTR2000038708。