Department of Obstetrics and Gynecology, Universidad de Navarra, Pamplona, Navarra, Spain.
Department of Radiology, Clínica Universidad de Navarra, Pamplona, Spain.
Int J Gynecol Cancer. 2023 Jun 5;33(6):951-956. doi: 10.1136/ijgc-2022-004253.
To determine the best second-step approach for discriminating benign from malignant adnexal masses classified as inconclusive by International Ovarian Tumour Analysis Simple Rules (IOTA-SR).
Single-center prospective study comprising a consecutive series of patients diagnosed as having an adnexal mass classified as inconclusive according to IOTA-SR. All women underwent Risk of Ovarian Malignancy Algorithm (ROMA) analysis, MRI interpreted by a radiologist, and ultrasound examination by a gynecological sonologist. Cases were clinically managed according to the result of the ultrasound expert examination by either serial follow-up for at least 1 year or surgery. Reference standard was histology (patient was submitted to surgery if any of the tests was suspicious) or follow-up (masses with no signs of malignancy after 12 months were considered benign). Diagnostic performance of all three approaches was calculated and compared. Direct cost analysis of the test used was also performed.
Eighty-two adnexal masses in 80 women (median age 47.6 years, range 16 to 73 years) were included. Seventeen patients (17 masses) were managed expectantly (none had diagnosis of ovarian cancer after at least 12 months of follow-up) and 63 patients (65 masses) underwent surgery and tumor removal (40 benign and 25 malignant tumors). Sensitivity and specificity for ultrasound, MRI, and ROMA were 96% and 93%, 100% and 81%, and 24% and 93%, respectively. The specificity of ultrasound was better than that for MRI (p=0.021), and the sensitivity of ultrasound was better than that for ROMA (p<0.001), sensitivity was better for MRI than for ROMA (p<0.001) and the specificity of ROMA was better than that for MRI (p<0.001). Ultrasound evaluation was the most effective and least costly method as compared with MRI and ROMA.
In this study, ultrasound examination was the best second-step approach in inconclusive adnexal masses as determined by IOTA-SR, but the findings require confirmation in multicenter prospective trials.
确定区分国际卵巢肿瘤分析简单规则（IOTA-SR）判定为不确定的良性和恶性附件肿块的最佳第二步方法。
单中心前瞻性研究包括一系列根据 IOTA-SR 被诊断为附件肿块不确定的连续患者。所有女性均接受卵巢癌风险算法（ROMA）分析、由放射科医生解读的 MRI 和妇科超声医生进行的超声检查。根据超声专家检查的结果，对病例进行临床管理，要么进行至少 1 年的连续随访，要么进行手术。参考标准为组织学（如果任何检查结果可疑，则进行手术）或随访（12 个月后无恶性迹象的肿块被认为是良性的）。计算并比较了所有三种方法的诊断性能。还进行了所用测试的直接成本分析。
共纳入 80 名女性的 82 个附件肿块（中位数年龄 47.6 岁，范围 16 岁至 73 岁）。17 名患者（17 个肿块）接受了期待治疗（至少 12 个月的随访后均未诊断出卵巢癌），63 名患者（65 个肿块）接受了手术和肿瘤切除（40 个良性和 25 个恶性肿瘤）。超声、MRI 和 ROMA 的敏感性和特异性分别为 96%和 93%、100%和 81%以及 24%和 93%。超声的特异性优于 MRI（p=0.021），超声的敏感性优于 ROMA（p<0.001），MRI 的敏感性优于 ROMA（p<0.001），而 ROMA 的特异性优于 MRI（p<0.001）。与 MRI 和 ROMA 相比，超声评估是最有效和成本最低的方法。
在这项研究中，超声检查是 IOTA-SR 判定为不确定的附件肿块的最佳第二步方法，但需要在多中心前瞻性试验中进一步证实。
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