Department of Pathology and Gynaecology, H Hartziekenhuis, Tienen, Belgium.
Eur J Cancer Prev. 2009 Aug;18(4):280-4. doi: 10.1097/CEJ.0b013e328329d885.
Recent innovations in tissue acquisition from the human breast have led to the development of unique direct frontal systems. We intend to evaluate efficacy and safety in a multicenter clinical study. Efficacy was considered optimal if the diagnosis by transcutaneous biopsy was identical to the surgical specimen in case of malignancy or in line with clinical follow-up when benign. One hundred and seventy-three women (aged 22-95 years) with a suspect lesion in the breast were eligible for transdermal biopsy. One hundred and seventeen biopsies were performed with the Spirotome and 56 with the Coramate under radiological or ultrasound guidance. Sample quality was evaluated by comparing the pathology results of the samples with definitive pathology at subsequent surgery or follow-up in case of benign lesions. An average of 1.66 biopsies per procedure were obtained. All patients had sufficient sample size (up to 5 mm diameter/20 mm length) to make a reliable diagnosis. The average length was 1.39 cm and the average diameter 3.72 mm. There were three false-negative diagnoses, leaving a correct diagnosis in 170 patients. None of the patients suffered from a serious complication, and the procedure was generally well tolerated. The new direct frontal transdermal tissue acquisition approach gives adequate diagnostic results through high-quality tissue samples. No major patient discomfort was noted.
最近在人体乳房组织采集方面的创新，导致了独特的直接正面系统的发展。我们打算在一项多中心临床研究中评估其疗效和安全性。如果经皮活检在恶性肿瘤的情况下与手术标本一致，或者在良性的情况下与临床随访一致，则认为诊断是最佳的。173 名（年龄 22-95 岁）乳房有可疑病变的女性符合经皮活检的条件。117 次活检是在 Spirotome 下进行的，56 次活检是在 Coramate 下进行的，均在放射学或超声引导下进行。通过比较样本的病理学结果与后续手术或良性病变的随访时的明确病理学结果，评估样本质量。平均每个程序获得 1.66 个活检样本。所有患者均有足够的样本量（直径达 5 毫米/长度达 20 毫米），可做出可靠的诊断。平均长度为 1.39 厘米，平均直径为 3.72 毫米。有 3 例假阴性诊断，170 例患者的诊断正确。没有患者出现严重并发症，该程序总体上耐受良好。新的直接正面经皮组织采集方法通过高质量的组织样本提供了足够的诊断结果。未观察到患者有明显不适。
