Pulmonology Unit, CHRU Tours, Tours, Centre, France
Chest Ultrasound Working Group (G-ECHO), Societe de Pneumologie de Langue Francaise, Paris, Île-de-France, France.
BMJ Open. 2021 Mar 25;11(3):e039078. doi: 10.1136/bmjopen-2020-039078.
Idiopathic pulmonary fibrosis (IPF) is the most common and severe interstitial lung disease (ILD). It is a progressive disease that requires a regular follow-up: clinical examination, pulmonary function testing (PFT) and CT scan, which is performed yearly in France. These exams have two major disadvantages: patients with severe dyspnoea have difficulties to perform PFT and repeated CT scans expose to high dose of radiations. Considering these limits, it would be relevant to develop new tools to monitor the progression of IPF lesions. Three main signs have been described in ILD with lung ultrasound (LUS): the number of B lines, the irregularity and the thickening of the pleural line. Cross-sectional studies already correlated the intensity of these signs with the severity of fibrosis lesions on CT scan in patients with IPF, but no prospective study described the evolution of the three main LUS signs, nor the correlation between clinical evaluation, PFT and CT scan. Our hypothesis is that LUS is a relevant tool to highlight the evolution of pulmonary lesions in IPF. The main objective of our study is to show an increase in one or more of the three main LUS signs (total number of B lines, pleural line irregularity score and pleural line thickness) during the follow-up.
ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution is a French prospective, multicentric and non-interventional study. Every 3 months, patients with IPF will have a clinical examination, PFT and LUS. CT data will be collected if the CT scan is performed within 3 months before the inclusion; the second CT scan will be performed from 9 to 12 months after the inclusion. The presence, location and severity of LUS signs will be recorded for each patient, and their correlation with clinical, functional and CT scan evolution will be evaluated. 30 patients will be enrolled.
The protocol was approved by the French Research Ethics Committee (Comité de Protection des Personnes SUD OUEST ET OUTRE MER II, reference RIPH3-RNI19-TOUPIE) on 11 April 2019. Results will be disseminated via peer-reviewed publication and presentation at international conferences.
NCT03944928;Pre-results.
特发性肺纤维化（IPF）是最常见和最严重的间质性肺疾病（ILD）。它是一种进行性疾病，需要定期随访：临床检查、肺功能测试（PFT）和 CT 扫描，在法国每年进行一次。这些检查有两个主要缺点：严重呼吸困难的患者难以进行 PFT，而重复 CT 扫描会暴露于高剂量辐射下。考虑到这些限制，开发新的工具来监测 IPF 病变的进展将是相关的。在肺超声（LUS）中已经描述了三种主要的ILD 征象：B 线的数量、胸膜线的不规则性和增厚。横断面研究已经将这些征象的强度与 IPF 患者 CT 扫描上纤维化病变的严重程度相关联，但没有前瞻性研究描述这三种主要 LUS 征象的演变，也没有描述临床评估、PFT 和 CT 扫描之间的相关性。我们的假设是，LUS 是突出 IPF 肺部病变演变的一种相关工具。我们的主要研究目标是在随访期间显示一种或多种三种主要 LUS 征象（B 线总数、胸膜线不规则评分和胸膜线厚度）的增加。
特发性肺纤维化演变的胸腔超声是一项法国前瞻性、多中心和非干预性研究。每 3 个月，IPF 患者将进行临床检查、PFT 和 LUS。如果在纳入前 3 个月内进行 CT 扫描，则收集 CT 数据；第二次 CT 扫描将在纳入后 9 至 12 个月进行。将记录每位患者的 LUS 征象的存在、位置和严重程度，并评估其与临床、功能和 CT 扫描演变的相关性。将纳入 30 名患者。
该方案于 2019 年 4 月 11 日获得法国伦理委员会的批准（法国南部和海外地区保护委员会，参考 RIPH3-RNI19-TOUPIE）。结果将通过同行评审的出版物和国际会议上的演讲进行传播。
NCT03944928；预结果。
