穿刺活检是基底细胞癌诊断和分型的金标准。本研究的目的是评估使用光学相干断层扫描(OCT)，一种无创成像工具，是否可以避免活检的需要。

在一项多中心、随机、非劣效性试验中，有面部H区(高危区)外疑似基底细胞癌活检指征的患者(年龄≥18岁)被随机分配(1:1)通过基于网络的随机分配系统接受OCT或打孔活检(常规护理)。患者来自荷兰的三个参与中心:马斯特里赫特大学医疗中心+、凯瑟琳娜医院埃因霍温和祖德兰德医疗中心海伦。随机分组的分层因素是参与中心和临床基底细胞癌疑似程度(高与低)。主要终点是治疗12个月后无复发或残留病变(恶性或癌前病变)的患者比例。进行了修改的意向治疗分析和按方案分析，预定义的非劣效性界限为-10%。

oct引导下对基底细胞癌的诊断和治疗并不次于常规护理穿孔活检。应用OCT诊断基底细胞癌，可减少会诊次数和侵袭性操作。

Abstract

Background: Punch biopsy is the gold standard for diagnosis and subtyping of basal cell carcinoma. The aim of this study was to assess whether use of optical coherence tomography (OCT), a non-invasive imaging tool, might avoid the need for biopsy.

Methods: In a multicentre, randomised, non-inferiority trial, patients (aged ≥18 years) with an indication for biopsy of a suspected basal cell carcinoma outside the H-zone (high-risk zone) of the face were randomly assigned (1:1) to receive either OCT or punch biopsy (regular care) via a web-based randomisation system. Patients were enrolled from three participating centres in the Netherlands: Maastricht University Medical Centre+, Catharina Hospital Eindhoven, and Zuyderland Medical Centre Heerlen. Stratification factors for randomisation were participating centre and the grade of clinical basal cell carcinoma suspicion (high vs low). The primary endpoint was the proportion of patients free from a recurrent or residual lesion (malignant or premalignant) 12 months after treatment. Modified intention-to-treat and per-protocol analyses were conducted, with a predefined non-inferiority margin of -10%. This trial is registered with ClinicalTrials.gov number, NCT03848078, and is complete.

Findings: Between Feb 25, 2019, and Sept 2, 2020, 598 patients were enrolled and randomly assigned to either the regular care group (n=299) or the OCT group (n=299). Data on the primary endpoint were available in 553 patients (n=268 in the regular care group, n=285 in the OCT group). After median follow-up of 12·7 months (IQR 11·2-14·1) in the OCT group and 12·6 months (10·8-14·3) in the regular care group, 253 (94%) of 268 patients in the OCT group and 266 (93%) of 285 patients in the regular care group were free from recurrent or residual lesions (malignant or pre-malignant) 12 months after treatment. According to our modified intention-to-treat analysis, the absolute difference (OCT vs regular care) was 1·07% (95% CI -2·93 to 5·06; one-sided p=0·30), with the lower limit of the 95% CI not exceeding the predefined non-inferiority margin of -10%. Per-protocol analyses led to proportions free from a residual or recurrent lesion (premalignant or malignant) of 95% (250 of 263) in the OCT group and 94% (262 of 278) in the regular care group, and an absolute difference of 0·81% (95% CI -2·98 to 4·60; one-sided p=0·34).

Interpretation: OCT-guided diagnosis and treatment of basal cell carcinoma is non-inferior to regular care punch biopsy. Implementation of OCT for diagnosis of basal cell carcinoma could reduce the number of consultations and invasive procedures.

原文链接：

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00347-3/fulltext

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