剪力波彈性超音波用於診斷肺部病變之效果及安全性：一個隨機分派臨床試驗

Abstract

背景︰超音波可用來幫助診斷肺部病灶，常用的方式為超音波同步導引進行細針抽吸及生檢切片，取得之抽吸物或生檢切片可送微生物培養、細胞學檢查、或病理檢查而得到診斷，以利後續治療之進行;剪力波彈性超音波以非侵入性方式客觀地量測組織的硬度，主要的原理是超音波機器會產生一推動波，此推動波會使肺部組織發生微小形變，繼而誘發出與推動波呈垂直之剪力波，剪力波之傳遞速度與肺部組織的硬度成正比，因此可以推算肺部組織之硬度。 方法：先前的觀察性研究發現剪力波彈性超音波可有效區分良性及惡性腫瘤，為了更進一步探討及驗證剪力波彈性超音波的診斷價值，本研究設計為一個隨機分派臨床試驗，實驗組為在剪力波彈性超音波導引下進行肺部腫瘤細針抽吸及生檢切片，先使用剪力波彈性超音波量測受試者肺部病灶的硬度，再針對硬度較高的區域進行細針抽吸及生檢切片；對照組為傳統超音波導引下進行細針抽吸及生檢切片，根據傳統的超音波亮度模式影像，由操作醫師決定進行細針抽吸及生檢切片的區域，本研究主要目的為比較二組之間的診斷效果及安全性有無差異。 結果：從2019年5月到2023年6月, 總共413位病人加入此隨機分派臨床試驗, 在最後分析中，有206位病人被分派為傳統超音波導引下進行細針抽吸及生檢切片, 205人被分派為剪力波彈性超音波導引下進行肺部腫瘤細針抽吸及生檢切片, 在傳統超音波導引組中, 有182位病人得到特定診斷 (88.4%) ; 而剪力波彈性超音波導引組則有194位病人(94.6%)得到特定診斷 (p=0.022). 剪力波彈性超音波導引組中有9.8%的病人，在生檢切片過程中變更切片目標區域, 而傳統超音波導引組中則有32.68%的病人變更切片目標區域 (P<0.001)。剪力波彈性超音波導引組所需的細針抽吸及生檢切片時間短於傳統超音波導引組 (12.8 ± 0.4 vs. 14.9 ± 0.5 分鐘, p<0.001)；在安全性方面，包括氣胸, 血胸, 或咳血, 二組均無統計上的顯著差異。 結論：我們藉由這個隨機分派臨床試驗，再次證實剪力波彈性超音波的診斷價值及安全性，在剪力波彈性超音波導引下進行細針抽吸及生檢切片, 可提高診斷率、減少侵入性檢查過程所需的時間、而且不會增加細針抽吸及生檢切片的風險。

Background: Shear-wave elastography (SWE) detects the propagation velocity of shear wave in the target lesion. The principle behind shear-wave elastography is that the transducer generates the ultrasonic burst and displaces the local tissues, shear waves representing the speed of tissue displacement propagation are generated. The speed of shear wave correlates to tissue stiffness, making it possible to calculate the stiffness of target tissues. As compared to strain elastography, shear-wave elastography does not require adjacent reference area. Accuracy is less operator-dependent. Methods: Based on the result of our prospective observation study, shear-wave elastography helps in the diagnosis of malignant subpleural pulmonary lesions. To remorselessly investigate the predictive value of shear-wave elastography, we conducted this randomized controlled trial to compare the diagnostic yield of shear-wave elastography-guided biopsy with the conventional transthoracic ultrasound-guided biopsy into the lung lesions. Results: From May 2019 to Jun 2023, a total of 413 patients were recruited and finally 206 patients randomized to the conventional ultrasound-guided biopsy group and 205 patients randomized to the shear-wave elastography-guided biopsy group were included in the analysis. Diagnosis was made in 182 patients (88.4%) randomized to the conventional ultrasound-guided biopsy group and 194 patients (94.6%) randomized to the shear-wave elastography-guided biopsy (p=0.022). Changing the target area for biopsy was encountered in 9.8% of the patients in the SWE-guided biopsy group and 32.68% of the patients in the conventional ultrasound-guided biopsy group (P<0.001). The procedure time was shorter in the shear-eave elastography-guided biopsy group than that in the conventional ultrasound-guided biopsy group (12.8 ± 0.4 vs. 14.9 ± 0.5 mins, p<0.001). The rate of pneumothorax, hemothorax, or hemoptysis did not differ significantly between the two groups. Conclusion: this randomized controlled trial found that shear-wave guided-biopsy had higher diagnostic yield and shorter procedure time compared with the conventional ultrasound-guided biopsy group.