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对于伴有可疑乳头溢液且乳腺 X 线摄影和超声检查均为阴性的患者,乳腺 MRI 的诊断准确性:一项前瞻性研究。

Diagnostic accuracy of breast MRI for patients with suspicious nipple discharge and negative mammography and ultrasound: a prospective study.

机构信息

Department of Radiology, Institut Bergonié, Comprehensive Cancer Centre, F-33076, Bordeaux, France.

Department of Radiology, Institut de Cancérologie de l'Ouest, Comprehensive Cancer Centre, F-44000, Saint-Herblain, France.

出版信息

Eur Radiol. 2021 Oct;31(10):7783-7791. doi: 10.1007/s00330-021-07790-4. Epub 2021 Apr 13.

Abstract

OBJECTIVES

To evaluate the diagnostic accuracy of breast MRI in identifying lesions requiring excision for patients with suspicious nipple discharge but normal mammograms and ultrasounds.

METHODS

Between September 2013 and May 2019, 106 female participants (mean age 57.9 years) were consecutively included in this prospective multicenter study; 102 were retained for analysis. MRI was considered negative in the absence of suspicious enhancement and positive in cases of ipsilateral abnormal enhancement (BI-RADS 3 to 5). Final diagnoses were based on histological findings of surgical or percutaneous biopsies or at 1-year follow-up. We considered all lesions requiring excision found on pathology (papilloma, atypia, nipple adenomatosis, or cancer) as positive results. We considered spontaneous resolution of the discharge at 1 year as a negative result.

RESULTS

MRI showed ipsilateral abnormal enhancement in 54 patients (53%) revealing 46 lesions requiring excision (31 benign papillomas, 5 papillomas with atypia, 2 nipple adenomatosis, and 8 cancers) and 8 benign lesions not requiring excision. No suspicious enhancement was found in the remaining 48 participants (47%). Forty-two were followed up at 1 year with spontaneous resolution of the discharge and six underwent surgery (revealing 2 benign papillomas). MRI diagnostic accuracy for the detection of a lesion requiring excision was as follows: sensitivity 96%, specificity 85%, positive predictive value 85%, and negative predictive value 96%.

CONCLUSION

In patients with suspicious nipple discharge and normal mammogram and ultrasound, MRI demonstrates excellent performance to identify lesions for which excision is required. Normal MRI indicates it is safe to propose follow-up only management, thus avoiding unnecessary duct excision.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02819362 KEY POINTS: • Breast MRI can be useful for the management of patients with suspicious nipple discharge and negative mammogram and ultrasound. • MRI detected a lesion requiring excision in 46 participants (45%) with unexplained discharge. • If breast MRI is negative, follow-up is a safe alternative for these patients.

摘要

目的

评估乳腺 MRI 对疑似乳头溢液但乳腺 X 线摄影和超声检查正常患者中需要切除的病灶的诊断准确性。

方法

在 2013 年 9 月至 2019 年 5 月期间,连续纳入 106 名女性参与者(平均年龄 57.9 岁)参与这项前瞻性多中心研究;102 名参与者被保留用于分析。如果没有可疑强化,且同侧出现异常强化(BI-RADS 3-5),则 MRI 结果为阴性。最终诊断基于手术或经皮活检的组织学发现,或在 1 年随访时。我们将所有在病理上需要切除的病灶(包括乳突瘤、非典型性、乳头腺瘤或癌症)视为阳性结果。将 1 年内溢液自发缓解视为阴性结果。

结果

MRI 显示 54 名患者(53%)同侧出现异常强化,其中 46 个病灶需要切除(31 个良性乳突瘤、5 个乳突瘤伴非典型性、2 个乳头腺瘤和 8 个癌症),8 个良性病灶无需切除。在其余 48 名参与者(47%)中未发现可疑强化。42 名参与者在 1 年时进行了随访,溢液自发缓解,6 名参与者接受了手术(发现 2 个良性乳突瘤)。MRI 对需要切除病灶的检测诊断准确性如下:敏感度 96%,特异度 85%,阳性预测值 85%,阴性预测值 96%。

结论

在疑似乳头溢液且乳腺 X 线摄影和超声检查正常的患者中,MRI 可用于识别需要切除的病灶,性能优异。正常的 MRI 表明,仅建议进行随访是安全的,从而避免不必要的乳管切除术。

临床试验注册

ClinicalTrials.gov NCT02819362

关键点

  • 乳腺 MRI 对疑似乳头溢液且乳腺 X 线摄影和超声检查正常的患者的管理具有一定价值。

  • MRI 检测到 46 名(45%)溢液不明原因的患者存在需要切除的病灶。

  • 如果乳腺 MRI 为阴性,对这些患者进行随访是一种安全的替代方法。

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