Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy.
Dermatology Clinic, Sapienza University of Rome, Rome, Italy.
JAMA Dermatol. 2022 Jul 1;158(7):754-761. doi: 10.1001/jamadermatol.2022.1570.
Previous systematic reviews and meta-analyses have concluded that given data paucity, a comparison of reflectance confocal microscopy (RCM) with dermoscopy is complex. They recommend comparative prospective studies in a real-world setting of suspect lesions.
To test the hypothesis that RCM reduces unnecessary lesion excision by more than 30% and identifies all melanoma lesions thicker than 0.5 mm at baseline.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial included 3165 patients enrolled from 3 dermatology referral centers in Italy between January 2017 and December 2019, with a mean (SD) follow-up of 9.6 (6.9) months (range, 1.9-37.0 months). The consecutive sample of 3165 suspect lesions determined through dermoscopy were eligible for inclusion (10 patients refused). Diagnostic analysis included 3078 patients (48 lost, 39 refused excision). Data were analyzed between April and September 2021.
Patients were randomly assigned 1:1 to standard therapeutic care (clinical and dermoscopy evaluation) with or without adjunctive RCM. Information available guided prospective clinical decision-making (excision or follow-up).
Hypotheses were defined prior to study initiation. All lesions excised (baseline and follow-up) were registered, including histopathological diagnoses/no change at dermoscopy follow-up (with or without adjunctive RCM). Number needed to excise (total number of excised lesions/number of melanomas) and Breslow thickness of delayed diagnosed melanomas were calculated based on real-life, prospective, clinical decision-making.
Among the 3165 participants, 1608 (50.8%) were male, and mean (SD) age was 49.3 (14.9) years. When compared with standard therapeutic care only, adjunctive RCM was associated with a higher positive predictive value (18.9 vs 33.3), lower benign to malignant ratio (3.7:1.0 vs 1.8:1.0), and a number needed to excise reduction of 43.4% (5.3 vs 3.0). All lesions (n = 15) with delayed melanoma diagnoses were thinner than 0.5 mm.
This randomized clinical trial shows that adjunctive use of RCM for suspect lesions reduces unnecessary excisions and assures the removal of aggressive melanomas at baseline in a real-life, clinical decision-making application for referral centers with RCM.
ClinicalTrials.gov Identifier: NCT04789421.
先前的系统评价和荟萃分析得出结论，鉴于数据不足，反射共聚焦显微镜 (RCM) 与皮肤镜检查的比较较为复杂。他们建议在可疑病变的实际环境中进行比较前瞻性研究。
测试假设，即 RCM 可减少超过 30%的不必要的病变切除，并在基线时识别所有厚度超过 0.5 毫米的黑色素瘤病变。
设计、地点和参与者：这项随机临床试验纳入了 2017 年 1 月至 2019 年 12 月期间从意大利 3 个皮肤科转诊中心招募的 3165 名患者，平均（标准差）随访时间为 9.6（6.9）个月（范围，1.9-37.0 个月）。通过皮肤镜检查确定的连续 3165 个可疑病变样本符合纳入条件（10 名患者拒绝）。诊断分析包括 3078 名患者（48 名失访，39 名拒绝切除）。数据于 2021 年 4 月至 9 月进行分析。
患者被随机分配到标准治疗护理（临床和皮肤镜检查评估）加或不加辅助 RCM。可用信息指导前瞻性临床决策（切除或随访）。
在研究启动前就定义了假设。所有切除的病变（基线和随访）均被记录，包括组织病理学诊断/皮肤镜检查随访无变化（有无辅助 RCM）。根据实际、前瞻性、临床决策计算需要切除的数量（切除的总病变数量/黑色素瘤数量）和延迟诊断的黑色素瘤的 Breslow 厚度。
在 3165 名参与者中，1608 名（50.8%）为男性，平均（标准差）年龄为 49.3（14.9）岁。与仅接受标准治疗护理相比，辅助 RCM 与更高的阳性预测值（18.9 比 33.3）、更低的良性与恶性比值（3.7:1.0 比 1.8:1.0）和 43.4%的需要切除数量减少（5.3 比 3.0）相关。所有（n=15）延迟诊断的黑色素瘤病变均较薄于 0.5 毫米。
这项随机临床试验表明，辅助 RCM 用于可疑病变可减少不必要的切除，并在 RCM 转诊中心的实际临床决策应用中确保在基线时切除侵袭性黑色素瘤。
ClinicalTrials.gov 标识符：NCT04789421。
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