在全甲状腺切除术中使用自发荧光和吲哚菁绿荧光成像联合识别和评估甲状旁腺：一项随机对照试验。
Combined Use of Autofluorescence and Indocyanine Green Fluorescence Imaging in the Identification and Evaluation of Parathyroid Glands During Total Thyroidectomy: A Randomized Controlled Trial.
机构信息
Department of Breast and Thyroid Surgery, Chongqing General Hospital, Chongqing, China.
Graduate School of Medicine, Chongqing Medical University, Chongqing, China.
出版信息
Front Endocrinol (Lausanne). 2022 Jun 16;13:897797. doi: 10.3389/fendo.2022.897797. eCollection 2022.
BACKGROUND AND OBJECTIVES
Accurate identification and evaluation of the parathyroid glands (PGs) intraoperatively is critical to reduce the incidence of postoperative hypoparathyroidism after total thyroidectomy. Near-infrared fluorescence imaging (NIFI), including the autofluorescence (AF) and indocyanine green fluorescence (ICGF) imaging, is a promising technique to protect PGs. This study aimed to assess whether the combined use of AF and ICGF could reduce the incidence of postoperative hypoparathyroidism and improve the identification and evaluation of PGs during total thyroidectomy.
METHODS
This randomized controlled trial enrolled 180 patients who were randomized into two groups and underwent total thyroidectomy with unilateral or bilateral central lymph node dissection. In the control group, the PGs were identified and evaluated by the naked eye. In the NIFI group, AF was used to identify the PGs and ICGF was applied to assess the blood perfusion of the PGs . The primary outcome was the incidence of postoperative hypoparathyroidism. The secondary outcomes included the number of identified PGs, autotransplanted PGs, and known preserved PGs .
RESULTS
The incidence of postoperative transient hypoparathyroidism was significantly lower in the NIFI group than in the control group (27.8% vs. 43.3%, = 0.029). More PGs were identified in the NIFI group than in the control group (3.6 ± 0.5 vs. 3.2 ± 0.4, < 0.001). No significant difference was observed in the number of autotransplanted PGs between the two groups ( = 0.134). Compared with the control group, a greater number of known PGs were preserved in the NIFI group (1.3 ± 0.6 vs. 1.0 ± 0.5, < 0.001). In the NIFI group, only 4.5% of the patients with at least one well-perfused PG (ICG score of 2) developed postoperative hypoparathyroidism, which was significantly lower than that of the control group (34.6%, < 0.001).
CONCLUSION
Combined use of AF and ICGF during total thyroidectomy reduces the risk of transient postoperative hypoparathyroidism, enhances the ability to identify and preserve PGs, and improves the accuracy of evaluating the perfusion of PGs during surgery.
CLINICAL TRIAL REGISTRATION
Chinese Clinical Trial Register (www.chictr.org.cn), identifier ChiCTR2100045320. Registered on April 12, 2021.
背景与目的
准确识别和评估甲状旁腺（PGs）对于减少甲状腺全切除术后甲状旁腺功能减退症的发生率至关重要。近红外荧光成像（NIFI），包括自发荧光（AF）和吲哚菁绿荧光（ICGF）成像，是一种有前途的保护 PGs 的技术。本研究旨在评估 AF 和 ICGF 的联合使用是否可以降低术后甲状旁腺功能减退症的发生率，并提高甲状腺全切除术中 PGs 的识别和评估。
方法
这项随机对照试验纳入了 180 名患者，他们被随机分为两组，并接受单侧或双侧中央淋巴结清扫术。在对照组中，通过肉眼识别和评估 PGs。在 NIFI 组中，使用 AF 识别 PGs，并应用 ICGF 评估 PGs 的血流灌注情况。主要结局是术后甲状旁腺功能减退症的发生率。次要结局包括识别的 PGs、自体移植的 PGs 和已知保留的 PGs 的数量。
结果
NIFI 组术后暂时性甲状旁腺功能减退症的发生率明显低于对照组（27.8%比 43.3%，=0.029）。NIFI 组识别的 PGs 数量多于对照组（3.6±0.5 比 3.2±0.4，<0.001）。两组间自体移植的 PGs 数量无显著差异（=0.134）。与对照组相比，NIFI 组更多的已知 PGs 得以保留（1.3±0.6 比 1.0±0.5，<0.001）。在 NIFI 组中，只有 4.5%至少有一个血流灌注良好的 PG（ICG 评分 2）的患者发生术后甲状旁腺功能减退症，明显低于对照组（34.6%，<0.001）。
结论
甲状腺全切除术中联合使用 AF 和 ICGF 可降低术后短暂性甲状旁腺功能减退症的风险，提高识别和保留 PGs 的能力，并提高手术中 PGs 灌注评估的准确性。
临床试验注册
中国临床试验注册中心（www.chictr.org.cn），注册号 ChiCTR2100045320。于 2021 年 4 月 12 日注册。
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