A Prospective Radiological Study of Thin-Section Computed Tomography to Predict Pathological Noninvasiveness in Peripheral Clinical IA Lung Cancer (Japan Clinical Oncology Group 0201)

A Prospective Radiological Study of Thin-Section Computed Tomography to Predict Pathological Noninvasiveness in Peripheral Clinical IA Lung Cancer (Japan Clinical Oncology Group 0201)
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DOI:
10.1097/jto.0b013e31821038ab
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发表时间:
2011-04-01
影响因子:
20.4
通讯作者:
Kato, Harubumi
Kato, Harubumi
中科院分区:
医学1区
文献类型:
--
作者:
Suzuki, Kenji;Koike, Teruaki;Kato, Harubumi

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目的:在早期肺癌患者术前影像学检查中,需要准确预测病理无创性,以便有限度的手术应用。患者和方法:招募临床T1N0M0外周肺癌患者。主要肿瘤的影像学表现在薄层计算机断层扫描上被评价为磨玻璃影。主要终点为特异性,即影像学诊断为浸润性肺癌患者与病理诊断为浸润性肺癌患者的比例。基于精度的计划样本量为450。我们预计,在bb0 = 97%的患者中,特异性的95%置信区间(CI)下限应得到满足。结果:从2002年12月至2004年5月,我们从31家医院入组了811例患者。在545例患者中评估了主要终点。病理诊断浸润性癌的特异性为96.4% (161/167,95% CI: 92.3 ~ 98.7%),敏感性为30.4% (115/378,95% CI: 25.8 ~ 35.3%),为阴性结果。然而,特异性对肺腺癌
Purpose: Pathological noninvasiveness needs to be precisely predicted in preoperative radiological examinations of patients with early lung cancer for the application of limited surgery.Patients and Methods: Patients with clinical T1N0M0 peripheral lung cancer were recruited. Radiological findings of the main tumor were evaluated as to ground-glass opacity with thin-section computed tomography. The primary end point was specificity, i.e., the proportion of patients with radiologically diagnosed invasive lung cancer to patients with pathologically diagnosed invasive lung cancer. The precision-based planned sample size was 450. We expected that the lower limit of the 95% confidence interval (CI) for specificity should be satisfied in >= 97% of patients.Results: We enrolled 811 patients from 31 institutions between December 2002 and May 2004. The primary end point was evaluated in 545 patients. The specificity and sensitivity for the diagnosis of pathologically diagnosed invasive cancer were 96.4% (161/167, 95% CI: 92.3-98.7%) and 30.4% (115/378, 95% CI: 25.8-35.3%), respectively, i.e., a negative result. Nevertheless, the specificity for lung adenocarcinoma