背景:经支气管纵隔冷冻活检是一种新的纵隔疾病采样技术。尽管肺癌有可能误诊,与标准支气管内超声引导下经支气管针吸活检术(EBUS-TBNA)相比,该方法对非肺癌病变的诊断率提高,凸显了其作为常规活检辅助技术的诊断潜力.我们旨在评估经支气管纵隔冷冻活检和标准EBUS-TBNA联合用于纵隔疾病诊断的安全性和附加值。
方法:我们进行了开放标签,在欧洲和亚洲的三家医院进行的随机试验。符合条件的患者年龄在15岁或以上,短轴上至少有一个1厘米或更长的纵隔病变,需要进行诊断支气管镜检查。参与者被随机分配(1:1)使用由计算机生成的区组随机化方案(根据独立统计学家的随机表格,四名参与者的区组大小),以合并使用EBUS-TBNA和经支气管纵隔冷冻活检(联合组)或单独使用EBUS-TBNA(对照组)。由于干预的性质,参与者和研究者均未被掩盖进行分组.共同主要结果是手术相关并发症和诊断率的差异(定义为纵隔活检导致明确诊断的参与者比例)。在完整的分析集中评估,包括所有符合入选标准并接受活检的患者.完全配对,对针吸活检和纵隔冷冻活检的参与者进行了个体内诊断分析,除了个体间的比较。该试验现已完成,并已在ClinicalTrials.gov注册,NCT04572984。
结果:在2020年10月12日至2021年9月9日之间,对297例连续患者的资格进行了评估,并将271例纳入并随机分配到联合组(n=136)或对照组(n=135)。在标准采样的基础上增加冷冻活检显著提高了纵隔病变的整体诊断率。如个体间(合并组136名参与者中的126[93%]与对照组135名参与者中的109[81%];风险比[RR]1·15[95%CI1·04-1·26];p=0·0039)和个体间(134名参与者中的126[94%]与134名参与者中的110[82%];RR1·15[95%CI1·05-1·26]=在个体内人群的亚组分析中,纵隔转移的诊断率相似(联合组69名参与者中有68名[99%],对照组69名参与者中有68名[99%];RR1·00[95%CI0·96-1·04];p=1·00),而在良性疾病中,联合方法比标准针吸更敏感(48例中的45[94%]对48例中的32[67%];RR1·41[95%CI1·14-1·74];p=0·0009)。组合方法还导致组织样品用于非小细胞肺癌的分子和免疫学分析的改善的适用性。与活检程序相关的不良事件的发生率在试验组之间没有差异。联合组3例(2%)和对照组2例(1%)发生3-4级气道出血(RR0·67[95%CI0·11-3·96];p=1·00)。无导致死亡或残疾的严重并发症。
结论:在标准EBUS-TBNA基础上加用纵隔冷冻活检可显著提高纵隔病变的诊断率,具有良好的安全性。这些数据表明,这种组合方法是纵隔疾病的有效一线诊断工具。
背景:国家自然科学基金.
Transbronchial mediastinal cryobiopsy is a novel sampling technique for mediastinal disease. Despite the possibility of lung cancer misdiagnosis, the improved diagnostic yield of this approach for non-lung-cancer lesions compared with standard endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) highlights its diagnostic potential as a complementary technique to conventional biopsy. We aimed to evaluate the safety profile and added value of the combined use of transbronchial mediastinal cryobiopsy and standard EBUS-TBNA for the diagnosis of mediastinal diseases.
We conducted an open-label, randomised
trial at three hospital sites in Europe and Asia. Eligible patients were aged 15 years or older, with at least one mediastinal lesion of 1 cm or longer in the short axis that required diagnostic bronchoscopy. Participants were randomly assigned (1:1) using a block randomisation scheme generated by a computer (block size of four participants based on a random table from an independent statistician) to the combined use of EBUS-TBNA and transbronchial mediastinal cryobiopsy (combined group) or EBUS-TBNA alone (control group). Because of the nature of the intervention, neither participants nor investigators were masked to group assignment. The coprimary outcomes were differences in procedure-related complications and diagnostic yield (defined as the proportion of participants for whom mediastinal biopsy led to a definitive diagnosis), assessed in the full analysis set, including all the patients who met the eligibility criteria and had a biopsy. A fully paired, intraindividual diagnostic analysis in participants who had both needle aspiration and mediastinal cryobiopsy was conducted, in addition to interindividual comparisons. This
trial is now complete and is registered with ClinicalTrials.gov, NCT04572984.
Between Oct 12, 2020, and Sept 9, 2021, 297 consecutive patients were assessed for eligibility and 271 were enrolled and randomly assigned to the combined group (n=136) or the control group (n=135). The addition of cryobiopsy to standard sampling significantly increased the overall diagnostic yield for mediastinal lesions, as shown by both interindividual (126 [93%] of 136 participants in the combined group vs 109 [81%] of 135 in the control group; risk ratio [RR] 1·15 [95% CI 1·04-1·26]; p=0·0039) and intraindividual (126 [94%] of 134 vs 110 [82%] of 134; RR 1·15 [95% CI 1·05-1·25]; p=0·0026) analyses. In subgroup analyses in the intraindividual population, diagnostic yields were similar for mediastinal metastasis (68 [99%] of 69 participants in the combined group vs 68 [99%] of 69 in the control group; RR 1·00 [95% CI 0·96-1·04]; p=1·00), whereas the combined approach was more sensitive than standard needle aspiration in benign disorders (45 [94%] of 48 vs 32 [67%] of 48; RR 1·41 [95% CI 1·14-1·74]; p=0·0009). The combined approach also resulted in an improved suitability of tissue samples for molecular and immunological analyses of non-small-cell lung cancer. The incidence of adverse events related to the biopsy procedure did not differ between
trial groups, as grade 3-4 airway bleeding occurred in three (2%) patients in the combined group and two (1%) in the control group (RR 0·67 [95% CI 0·11-3·96]; p=1·00). There were no severe complications causing death or disability.
The addition of mediastinal cryobiopsy to standard EBUS-TBNA resulted in a significant improvement in diagnostic yield for mediastinal lesions, with a good safety profile. These data suggest that this combined approach is a valid first-line diagnostic tool for mediastinal diseases.
National Natural Science Foundation of China.