目的:出血是经支气管镜肺冷冻活检(TBLC)的主要并发症,预先放置支气管球囊是预防支气管球囊的临床实践之一,但是证据非常薄弱,这应该得到证实。本研究旨在研究在TBLC中预先放置支气管球囊诊断间质性肺病(ILD)是否更安全。
方法:在此前瞻性中,单中心,随机对照试验,本研究纳入疑似ILD患者,并将其随机分为预置球囊组和未预置球囊组.主要结果是每组的中度出血发生率。次要终点是严重出血的发生率,气胸,和其他手术并发症。
结果:2019年8月至2022年3月共纳入250例患者,每组125例。未预先放置球囊组和预先放置球囊组之间的严重出血没有显着差异(1.6%vs.0.8%;调整后p=0.520),而未预先放置球囊组的出血更中度(26.4%vs.6.4%,调整后的p=0.001),以及更多使用止血药物(28.0%vs.6.4%,调整后的p=0.001)。未预先放置的球囊组中的三名患者使用了支气管球囊。与未预先放置的球囊组相比,预先放置的球囊组可以获得更多的样本(3.8±0.9vs.3.1±0.9,p<0.001)。两组之间的多学科讨论(MDD)没有显着差异(89.6%vs.91.2%,调整后的p=0.182)。
结论:预先放置支气管球囊可以减少中度出血的发生率,增加支气管镜医师的信心。然而,对提高MDD的诊断率和减少严重出血没有影响。
背景:NCT04047667(www.
结果:gov标识符)。
OBJECTIVE: Bleeding is a major complication of transbronchial lung cryobiopsy (TBLC), and pre-placing a bronchial balloon is one of the clinical practices used to prevent it, but with very weak evidence, which should be confirmed. This study aimed to conduct whether pre-placing a bronchial balloon in TBLC for diagnosing interstitial lung disease (ILD) is more safety.
METHODS: In this prospective, single-center, randomized controlled trial, patients with suspected ILD were enrolled and randomly assigned to pre-placed balloon and none-pre-placed balloon groups. The primary outcome was incidence of moderate bleeding in each group. The secondary endpoints were the incidence of severe bleeding, pneumothorax, and other procedural complications.
RESULTS: Exactly 250 patients were enrolled between August 2019 and March 2022, with 125 in each group. There were no significant differences in severe bleeding between the none-pre-placed balloon group and pre-placed balloon group (1.6% vs. 0.8%; adjusted p = 0.520), while more moderate bleeding occurred in the none-pre-placed balloon group (26.4% vs. 6.4%, adjusted p = 0.001), as well as more use of hemostatic drug (28.0% vs. 6.4%, adjusted p = 0.001). Three patients in the none-pre-placed balloon group used the bronchial balloon. More samples could be acquired in the pre-placed balloon group than in the none-pre-placed balloon group (3.8 ± 0.9 vs. 3.1 ± 0.9, p < 0.001). There were no significant differences in multidisciplinary discussion (MDD) between the two groups (89.6% vs. 91.2%, adjusted p = 0.182).
CONCLUSIONS: A pre-placed bronchial balloon can reduce the incidence of moderate bleeding and increase the confidence of the bronchoscopists. However, it had no effect on increasing the diagnostic rate of MDD and reducing severe bleeding.
BACKGROUND: NCT04047667 ( www.
RESULTS: gov identifier).