St Josephs Hospital, Radiology Limited, PLC, Tucson, Arizona, USA.
J Vasc Interv Radiol. 2010 Aug;21(8):1235-43.e1-3. doi: 10.1016/j.jvir.2010.04.021.
To evaluate the ability of an expanding hydrogel lung biopsy tract plug ("plug") to reduce rates of pneumothoraces and other complications associated with computed tomography (CT)-guided lung biopsy.
A total of 339 subjects (mean age, 67 years) who underwent lung biopsy of indeterminate masses, without immediate postsample CT evidence of a pneumothorax, were randomized at 15 U.S. centers. Treatment subjects (n = 170) received a plug deployed through the coaxial needle just before the needle was removed. Control subjects (n = 169) did not receive a plug. The primary end point was defined as the absence of pneumothorax on chest radiographs at all three required postprocedure assessments (30- to 60-minute, 24-hour, 30-day); analysis was stratified by any smoking history and study site. A central laboratory performed blinded independent interpretation of the radiographs.
Among the 287 subjects who completed all postprocedure assessments, significantly more treatment subjects than control subjects achieved the primary end point (127 of 150, 85% vs 95 of 137, 69%; P = .002). Among all 339 randomized subjects, the odds of achieving the primary end point were 4.4 times greater for nonsmokers than they were for smokers (95% confidence interval, 1.7, 11.0; P = 0.002); study site had no statistically significant effect. Compared with control subjects, treatment subjects had fewer pneumothoraces (30 of 170, 18% vs 53 of 169, 31%), fewer chest tubes placed (6 of 170, 4% vs 18 of 169, 11%), and fewer postbiopsy hospital admissions (16 of 170, 9% vs 23 of 169, 14%).
The lung biopsy tract plug significantly reduced rates of pneumothorax in patients undergoing CT-guided lung biopsy. Rates of chest tube placement and postprocedure hospital admission were also reduced.
评估可扩张水凝胶肺活检通道塞（“塞子”）减少与 CT 引导下肺活检相关的气胸和其他并发症发生率的能力。
在 15 个美国中心，共有 339 名（平均年龄 67 岁）接受了不确定肿块的肺活检，且在取样后即刻 CT 检查没有气胸证据的患者进行了随机分组。治疗组（n=170）在同轴针即将拔出时通过同轴针置入塞子。对照组（n=169）未置入塞子。主要终点定义为在所有 3 次后续评估（30-60 分钟、24 小时和 30 天）时，胸部 X 线均无气胸；分析按有无吸烟史和研究地点进行分层。一个中心实验室对 X 线片进行了盲法独立解读。
在完成所有后续评估的 287 名患者中，治疗组患者较对照组患者更符合主要终点（150 例中的 127 例[85%] vs. 137 例中的 95 例[69%]；P=0.002）。在所有 339 名随机患者中，非吸烟者较吸烟者达到主要终点的可能性高 4.4 倍（95%置信区间，1.7 至 11.0；P=0.002）；研究地点无统计学意义。与对照组相比，治疗组气胸（170 例中的 30 例[18%] vs. 169 例中的 53 例[31%]）、胸腔引流管置入（170 例中的 6 例[4%] vs. 169 例中的 18 例[11%]）和活检后住院治疗（170 例中的 16 例[9%] vs. 169 例中的 23 例[14%]）的发生率均较低。
肺活检通道塞可显著降低 CT 引导下肺活检患者的气胸发生率。胸腔引流管放置率和术后住院率也有所降低。
