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一项耳鼻喉科荧光引导手术临床试验的范围综述

A Scoping Review of Ongoing Fluorescence-Guided Surgery Clinical Trials in Otolaryngology.

机构信息

Department of Surgery, Division of Otolaryngology-Head and Neck Surgery, University of California San Diego, San Diego, California, U.S.A.

Department of Otolaryngology-Head and Neck Surgery, Stanford University, Palo Alto, California, U.S.A.

出版信息

Laryngoscope. 2022 Jan;132(1):36-44. doi: 10.1002/lary.29891. Epub 2021 Oct 11.

DOI:10.1002/lary.29891
PMID:34633092
Abstract

OBJECTIVE

Fluorescence-guided surgery (FGS) is a rapidly developing intraoperative technology, and many contrast agents are currently under investigation. We sought to provide a review of the current state of FGS clinical trials in Otolaryngology, emphasizing its oncologic applications.

METHODS

According to the preferred reporting Items for systematic reviews and meta-analyses (PRISMA) workflow for scoping reviews, a clinical trial search was performed across multiple international clinical trials registries, searching for permutations of "fluorescence," "tumor," "surgery," and "nerve" to identify all relevant studies. Studies that were active, enrolling, or soon to be enrolling patients undergoing head and neck surgery were included.

RESULTS

Nineteen studies were eligible for inclusion. Seventeen studies are focused on FGS for oncologic resection and lymph node detection. One study assesses peripheral nerve fluorescence, and one evaluates normal parathyroid function after thyroidectomy. Contrast agents under development are conjugated to fluorophores that excite in the 800 nm (indocyanine green), 410 nm (5-aminolevulinic acid), 700 nm (Cyanine 5.5), and 525 nm ranges (fluorescein derivatives).

CONCLUSION

Presently, there are 19 ongoing trials investigating novel FGS contrast agents for their safety, efficacy, and utility in Otolaryngology-Head and Neck Surgery. These agents rely on unique fluorophores and absorption ranges in the near-infrared and visible light spectra. FGS studies are expanding within Otolaryngology-Head and Neck Surgery with profound implications in oncologic surgery, lymph node detection, and anatomic and functional assessment. Laryngoscope, 132:36-44, 2022.

摘要

目的

荧光引导手术(FGS)是一种快速发展的术中技术,目前有许多造影剂正在研究中。我们旨在提供一篇综述,重点介绍其在耳鼻喉科肿瘤学中的应用,概述 FGS 在耳鼻喉科的临床试验现状。

方法

根据系统评价和荟萃分析的首选报告项目(PRISMA)的范围综述工作流程,对多个国际临床试验注册中心进行了临床试验搜索,搜索了“荧光”、“肿瘤”、“手术”和“神经”的各种组合,以确定所有相关研究。纳入正在招募或即将招募头颈部手术患者的活跃、入组或即将入组的研究。

结果

有 19 项研究符合纳入标准。17 项研究专注于 FGS 在肿瘤切除和淋巴结检测方面的应用。一项研究评估外周神经荧光,一项研究评估甲状腺切除术后甲状旁腺功能正常。正在开发的造影剂与在 800nm(吲哚菁绿)、410nm(5-氨基乙酰丙酸)、700nm(Cyanine 5.5)和 525nm 范围内激发的荧光团偶联。

结论

目前,有 19 项正在进行的研究正在调查新型 FGS 造影剂在耳鼻喉头颈外科的安全性、有效性和实用性。这些造影剂依赖于近红外和可见光光谱中独特的荧光团和吸收范围。FGS 研究在耳鼻喉头颈外科领域不断扩展,对肿瘤手术、淋巴结检测以及解剖和功能评估具有深远意义。《喉镜》,132:36-44,2022 年。

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