Cousart Alexandria G, Kiernan Colleen M, Willmon Parker A, Thomas Giju, Wang Tracy S, Gauger Paul G, Duh Quan-Yang, Underwood Hunter J, Jackson Anee, Patel Anuradha, Mahadevan-Jansen Anita, Solórzano Carmen C
Vanderbilt Biophotonics Center, Vanderbilt University, Nashville, Tennessee.
Department of Biomedical Engineering, Vanderbilt University, Nashville, Tennessee.
JAMA Surg. 2025 Jul 16. doi: 10.1001/jamasurg.2025.2233.
Inadvertent removal and damage to parathyroid glands (PGs) can lead to hypoparathyroidism, making it crucial to accurately identify and preserve these glands during parathyroidectomy and thyroidectomy.
To assess if fiber-based near-infrared autofluorescence (NIRAF) increases the number of intraoperatively identified PGs and reduces the occurrence of hypoparathyroidism.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter randomized clinical trial with a 6-month follow-up was conducted between March 2020 and July 2024. It included 4 medical centers across the US, 4 senior (more than 10 years of experience) and 3 junior (less than 5 years of experience) surgeons. A total of 754 patients were enrolled and 752 were randomized, including 398 patients (2 withdrew) who underwent parathyroidectomy and 354 patients who had total/completion thyroidectomy. Data were analyzed from March 2020 to January 2025.
Use of fiber-based NIRAF during thyroidectomy and parathyroidectomy.
The primary outcome was the mean number of PGs identified intraoperatively. The secondary outcome was the rate of hypoparathyroidism (transient and at last follow-up).
Of 752 patients randomized, 712 were analyzed for the primary outcome (94.4%) (overall median [IQR] age, 59 [25] years; 516 females [68.4%]). A total of 161 underwent parathyroidectomy with NIRAF, while 159 had conventional surgery. Additionally, 176 underwent thyroidectomy using NIRAF and 178 had traditional surgery. The mean number of PGs identified during parathyroidectomy was not significantly higher when using NIRAF for focused procedures (mean, NIRAF, 1.6; 95% CI, 1.4-1.8 vs control, 1.5; 95% CI, 1.4-1.7). During bilateral explorations, the surgeons improved in the mean number of PGs identified when using NIRAF (mean NIRAF, 3.5; 95% CI, 3.4-3.7 vs control, 3.2; 95% CI, 3.0-3.4; P < .001). During thyroidectomy, the mean number of PGs identified increased when using NIRAF (mean NIRAF, 3.3; 95% CI, 3.2-3.4 vs control, 2.8; 95% CI, 2.7-3.0; P < .001). There was no significant difference in hypoparathyroidism after thyroidectomy, either transient (NIRAF: 48 of 173 patients [27.8%]; control: 44 of 169 patients [26%]) or at the last follow-up (NIRAF: 3 of 176 patients [1.7%]; control: 6 of 176 patients [3.4%]).
Fiber-based NIRAF can increase the number of PGs identified during thyroidectomy and bilateral exploration parathyroidectomy without increasing the duration of the surgery.
ClinicalTrials.gov Identifiers: NCT05579782, NCT05022667, NCT05022641, NCT04281875, NCT04299425, NCT05152927.
甲状旁腺（PG）的意外切除和损伤可导致甲状旁腺功能减退，因此在甲状旁腺切除术和甲状腺切除术中准确识别并保留这些腺体至关重要。
评估基于光纤的近红外自发荧光（NIRAF）是否能增加术中识别出的PG数量，并降低甲状旁腺功能减退的发生率。
设计、设置和参与者：这项多中心随机临床试验，随访期为6个月，于2020年3月至2024年7月进行。它包括美国的4个医疗中心、4名资深（超过10年经验）和3名初级（少于5年经验）外科医生。共有754名患者入组，752名被随机分组，其中398例（2例退出）接受了甲状旁腺切除术，354例接受了全甲状腺切除/甲状腺次全切除术。对2020年3月至2025年1月的数据进行了分析。
在甲状腺切除术和甲状旁腺切除术中使用基于光纤的NIRAF。
主要结局是术中识别出的PG的平均数量。次要结局是甲状旁腺功能减退的发生率（短暂性和最后一次随访时）。
在752名随机分组的患者中，712名（94.4%）被分析了主要结局（总体年龄中位数[四分位间距]为59[25]岁；516名女性[68.4%]）。共有161例使用NIRAF进行甲状旁腺切除术，159例进行传统手术。此外，176例使用NIRAF进行甲状腺切除术，178例进行传统手术。在甲状旁腺切除术中，对于有针对性的手术，使用NIRAF时识别出的PG平均数量没有显著更高（平均值，NIRAF组为1.6；95%置信区间，1.4 - 1.8，对照组为1.5；95%置信区间，1.4 - 1.7）。在双侧探查中，外科医生使用NIRAF时识别出的PG平均数量有所增加（平均值，NIRAF组为3.5；95%置信区间，3.4 - 3.7，对照组为3.2；95%置信区间，3.0 - 3.4；P < 0.001）。在甲状腺切除术中，使用NIRAF时识别出的PG平均数量增加（平均值，NIRAF组为3.3；95%置信区间，3.2 - 3.4，对照组为2.8；95%置信区间，2.7 - 3.0；P < 0.001）。甲状腺切除术后甲状旁腺功能减退无论是短暂性的（NIRAF组：173例患者中有48例[27.8%]；对照组：169例患者中有44例[26%]）还是在最后一次随访时（NIRAF组：176例患者中有3例[1.7%]；对照组：176例患者中有6例[3.4%]）均无显著差异。
基于光纤的NIRAF可增加甲状腺切除术和双侧探查甲状旁腺切除术中识别出的PG数量，且不增加手术时长。
ClinicalTrials.gov标识符：NCT05579782、NCT05022667、NCT05022641、NCT04281875、NCT04299425、NCT05152927。
