国产支气管内超声用于肺周围型病变检查的动物实验研究

Application of a self-developed medical radial probe intratracheal ultrasound in examination of peripulmonary lesions: An animal experimental study

  • 摘要:
      背景  常规支气管镜诊断技术对于肺周围型病变诊断具有一定局限性,联合径向探头支气管内超声可以显著提高诊断率,临床上也将其作为早期肺癌诊断的重要工具。
      目的  通过动物实验以及离体猪肺实验评价自主研发的医用径向探头支气管内超声检查的可行性、操作性能和安全性。
      方法  广西巴马小型猪8只,由4名具有5年呼吸内镜操作经验的医师先后应用自主研发的径向探头支气管内超声(实验组)和奥林巴斯公司的UM-S20-17S型径向探头支气管内超声(对照组)对每只巴马型小猪进行检查,采用自身对照方法,根据掷硬币法随机决定对同一只巴马型小猪进行两种支气管内超声检查的先后顺序,检查后采用量化评分法评价两种支气管内超声的操作性能及安全性。应用8个离体猪肺,分离离体猪肺局部肺段以下支气管,在分离的肺段支气管旁植入食用果冻模拟建立的体外肿瘤模型,采用自身对照方法,应用自主研发的VsonicPro2017C型径向探头支气管内超声(实验组)和奥林巴斯公司的UM-S20-17S型支气管内超声(对照组)对肿瘤模型进行检查,应用量化评分法评价两种支气管内超声对肿瘤模型的分辨能力和肿瘤回声特征判定能力。
      结果  与主机连接是否方便(7.56±0.21 vs 7.84±0.18)、插入活检孔道的难易程度(7.47±0.26 vs 7.94±0.13)、超声插入活检孔道后是否可以正常工作(7.53±0.22 vs 7.84±0.34)、图像采集和储存(7.53±0.12 vs 7.94±0.18)、图像质量是否符合质量要求评分(7.38±0.24 vs 7.69±0.17)方面,两组差异均无统计学意义(P均>0.05)。两组肿瘤分辨能力(7.66±0.22 vs 7.84±0.21)、肿瘤回声特征判定能力评分(7.63±0.28 vs 7.84±0.51)亦无统计学差异(P均>0.05)。两组均无相关并发症。
      结论  自主研发的径向探头支气管内超声(VsonicPro2017C)操作安全、可行、简便,能清晰观察支气管旁病变特征,其操作性能和采集图像质量良好,具有良好应用前景。

     

    Abstract:
      Background  With the rapid development of respiratory intervention technology, especially the appearance of intrabronchial ultrasound with radial probe, the diagnosis rate of peripheral pulmonary lesions is significantly improved, and it is an important tool for the diagnosis of early lung cancer.
      Objective  To evaluate the feasibility, performance and safety of intratracheal ultrasound examination with self-developed medical radial probe through animal experiments and isolated pig lung experiments.
      Methods  Eight Guangxi Bama miniature pigs were examined by 4 physicians with 5-year experience in respiratory endoscopy using the self-developed radial probe intratracheal ultrasound (experimental group) and Olympus's UM-S20-17s radial probe intratracheal ultrasound (control group). The self-control method was used. According to the method of flipping a coin, the sequence of the two kinds of endobronchial ultrasound examination in the same Bama piglet was randomly determined, and the quantitative scoring method was used to evaluate the operation performance and safety of the two kinds of endobronchial ultrasound. Eight isolated pig lungs were used to separate the local subsegmental bronchi, and edible jelly was implanted next to the isolated segmental bronchi to establish an in vitro tumor model. The tumor model was examined by self-control method with the self-developed VsonicPro2017C radial probe bronchial ultrasound (experimental group) and Olympus UM-S20-17s endobronchial ultrasound (control group). The quantitative scoring method was used to evaluate the distinguishing ability of two kinds of endobronchial ultrasound to tumor model and the ability to judge the echo characteristics of tumor.
      Results  There were no significant differences in the scores of whether it was convenient to connect with the host (7.56±0.21 vs 7.84±0.18), the difficulty of inserting the biopsy channel (7.47±0.26 vs 7.94±0.13), whether the ultrasound could work normally after inserting the biopsy channel (7.53±0.22 vs 7.84±0.34), the image acquisition and storage (7.53±0.12 vs 7.94±0.18), and whether the image quality met the quality requirements (7.38±0.24 vs 7.69±0.17) between the two groups (all P>0.05). The scores of tumor resolution and tumor echo characteristics in the experimental group and the control group were 7.66±0.22 vs 7.84±0.21, 7.63±0.28 vs 7.84±0.51, respectively, without significant difference between the two groups (P>0.05). No related complication was found in both the experimental group and the control group.
      Conclusion  The self-developed radial probe intratracheal ultrasound (VsonicPro2017C) is safe, feasible and simple, it can clearly observe the characteristics of parabolic lesions with good operation performance and image quality, which has a good application prospect.

     

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