Garset-Zamani Martin, Hvilsom Gitte Bjørn, Kjærgaard Thomas, O'Leary Padraig, Wennervaldt Kasper, Bøgh Mads, Hahn Christoffer Holst, Kaltoft Mikkel, Plaschke Christina Caroline, Mikkelsen Ronni, Norling Rikke, Dejanovic Danijela, Hall Johanna Maria, Agander Tina Klitmøller, Wessel Irene, Ersbøll Annette Kjær, von Buchwald Christian, Todsen Tobias
Department of Otorhinolaryngology, Head and Neck Surgery, and Audiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
JAMA Otolaryngol Head Neck Surg. 2025 Jul 17. doi: 10.1001/jamaoto.2025.1954.
Early-stage oropharyngeal squamous cell carcinoma (OPSCC) is challenging to diagnose using clinical examination and cross-sectional imaging. Ultrasonography performed transorally can provide high-resolution images of oropharyngeal structures; however, whether it improves diagnostic evaluation of patients with suspected OPSCC is unknown, and yet there is a need for improved early detection and T staging.
To compare the accuracy of clinical examination, ultrasonography, and magnetic resonance imaging (MRI) in detection of oropharyngeal tumors.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter diagnostic clinical trial was conducted in the outpatient clinics of 3 tertiary cancer centers. Consecutive patients with suspected OPSCCs or neck metastases (without visible primary tumors) were screened from February 1, 2023, to June 30, 2024, and those eligible after a clinical examination by a head and neck surgeon were included. Exclusion criteria were a prior head and neck cancer diagnosis or a known histopathologically or imaging-verified oropharyngeal tumor present. Data were analyzed from August 1 to October 31, 2024.
Surgeon-performed transoral and transcervical ultrasonography of the oropharynx during initial clinical examination followed by cross-sectional imaging (MRI) that was evaluated blinded to results of ultrasonography and histopathologic testing.
Oropharyngeal tumor detection with reference to final histopathologic results (presence or absence of an oropharyngeal tumor).
The study included 162 participants (median [range] age, 63 [32-85] years; 58 female [35%] and 105 male [65%]), of whom 106 (65%) had an oropharyngeal tumor (OPSCC, 95 [59%]; lymphoma, 7 [4%]; other type, 4 [5%]). Ultrasonography had significantly higher overall accuracy (139 patients [86%]) in correctly diagnosing patients compared to clinical examination (110 [68%]; odds ratio [OR], 0.31; 95% CI, 0.18-0.52) and MRI (123 [76%]; OR, 0.48; 95% CI, 0.28-0.82). The sensitivity of the 3 diagnostic methods to detect oropharyngeal tumors was similar (ultrasonography, 95 patients [90%]; clinical examination, 87 [82%]; MRI, 97 [92%]); however, ultrasonography demonstrated nearly twice the level of specificity in the 56 patients without tumors (44 patients [79%] vs 23 [41%] and 26 [46%], respectively).
This diagnostic clinical trial found that surgeon-performed transoral and transcervical ultrasonography in patients with suspected OPSCC provided higher diagnostic accuracy than clinical examination alone or MRI. Ultrasonography improves the clinical evaluation of suspected oropharyngeal cancers by providing higher diagnostic certainty.
早期口咽鳞状细胞癌(OPSCC)通过临床检查和横断面成像进行诊断具有挑战性。经口超声检查可以提供口咽结构的高分辨率图像;然而,它是否能改善疑似OPSCC患者的诊断评估尚不清楚,且仍需要改进早期检测和T分期。
比较临床检查、超声检查和磁共振成像(MRI)在检测口咽肿瘤方面的准确性。
设计、设置和参与者:这项多中心诊断性临床试验在3个三级癌症中心的门诊进行。从2023年2月1日至2024年6月30日对疑似OPSCC或颈部转移瘤(无可见原发肿瘤)的连续患者进行筛查,经头颈外科医生临床检查后符合条件的患者纳入研究。排除标准为既往有头颈癌诊断或已知有组织病理学或影像学证实的口咽肿瘤。于2024年8月1日至10月31日进行数据分析。
在初始临床检查期间由外科医生进行口咽的经口和经颈超声检查,随后进行横断面成像(MRI),对超声检查和组织病理学检测结果进行盲法评估。
参照最终组织病理学结果(口咽肿瘤的存在与否)检测口咽肿瘤。
该研究纳入了162名参与者(年龄中位数[范围]为63[32 - 85]岁;58名女性[35%]和105名男性[65%]),其中106名(65%)患有口咽肿瘤(OPSCC,95名[59%];淋巴瘤,7名[4%];其他类型,4名[5%])。与临床检查(110名[68%];比值比[OR],0.31;95%置信区间,0.18 - 0.52)和MRI(123名[76%];OR,0.48;95%置信区间,0.28 - 0.82)相比,超声检查在正确诊断患者方面具有显著更高的总体准确性(139名患者[86%])。这三种诊断方法检测口咽肿瘤的敏感性相似(超声检查,95名患者[90%];临床检查,87名[82%];MRI,97名[92%]);然而,在56名无肿瘤的患者中,超声检查的特异性水平几乎是其他两者的两倍(分别为44名患者[79%],而临床检查为23名[41%],MRI为26名[46%])。
这项诊断性临床试验发现,对于疑似OPSCC患者,由外科医生进行的经口和经颈超声检查比单独的临床检查或MRI具有更高的诊断准确性。超声检查通过提供更高的诊断确定性改善了对疑似口咽癌的临床评估。