Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins School of Medicine, Baltimore, MD, United States.
i2KIE LLC, Gaithersburg, MD, United States.
Front Endocrinol (Lausanne). 2023 Jul 24;14:1190282. doi: 10.3389/fendo.2023.1190282. eCollection 2023.
Parathyroid glands may be compromised during thyroid surgery which can lead to hypoparathyroidism and hypocalcemia. Identifying the parathyroid glands relies on the surgeon's experience and the only way to confirm their presence was through tissue biopsy. Near infrared autofluorescence technology offers an opportunity for real-time, non-invasive identification of the parathyroid glands.
We used a new research prototype (hANDY-I) developed by Optosurgical, LLC. It offers coaxial excitation light and a dual-Red Green Blue/Near Infrared sensor that guides anatomical landmarks and can aid in identification of parathyroid glands by showing a combined autofluorescence and colored image simultaneously.
We tested the imager during 23 thyroid surgery cases, where initial clinical feasibility data showed that out of 75 parathyroid glands inspected, 71 showed strong autofluorescence signal and were correctly identified (95% accuracy) by the imager.
The hANDY-I prototype demonstrated promising results in this feasibility study by aiding in real-time visualization of the parathyroid glands. However, further testing by conducting randomized clinical trials with a bigger sample size is required to study the effect on levels of hypoparathyroidism and hypocalcemia.
甲状旁腺在甲状腺手术中可能会受到损伤，导致甲状旁腺功能减退和低钙血症。甲状旁腺的识别依赖于外科医生的经验，而确认其存在的唯一方法是通过组织活检。近红外自体荧光技术为实时、非侵入性识别甲状旁腺提供了机会。
我们使用了 Optosurgical, LLC 开发的新型研究原型（hANDY-I）。它提供了同轴激发光和一个双红-绿-蓝/近红外传感器，可引导解剖学标志，并通过同时显示自体荧光和彩色图像来辅助识别甲状旁腺。
我们在 23 例甲状腺手术中测试了该成像仪，初步临床可行性数据显示，在检查的 75 个甲状旁腺中，有 71 个显示出强烈的自体荧光信号，并被成像仪正确识别（准确率为 95%）。
hANDY-I 原型在这项可行性研究中表现出了有前景的结果，通过实时可视化甲状旁腺来辅助手术。然而，需要进行更大样本量的随机临床试验来研究其对甲状旁腺功能减退和低钙血症水平的影响。
