甲状腺手术中术中吲哚菁绿荧光成像：技术方案、评估窗口及判读陷阱——42例前瞻性系列的单中心经验

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中文摘要

背景： 术后甲状旁腺功能减退仍是全甲状腺切除术最常见的并发症（暂时性20-40%，永久性1-4%）。术中近红外成像联合吲哚菁绿（ICG）已被验证可用于甲状旁腺（PG）灌注评估——EAES 2023共识已认可——但关于实际实施、时间参数和判读陷阱的数据仍然有限。
目的： 描述使用Karl Storz IMAGE1 S™ Rubina®系统的ICG技术方案，量化评估窗口（tev）并系统化所遇到的判读陷阱。
材料和方法： 前瞻性、观察性、单中心研究（对前瞻性收集数据的回顾性分析；入组取决于术中ICG制剂的可用性，因此并非严格连续），纳入42例在甲状腺手术中使用术中ICG的病例（37名女性，5名男性；平均年龄52.6岁；BMI 27.5 kg/m²），手术于2024年2月至2025年2月期间进行。统一方案：在估计皮肤至皮肤时间的约66%时静脉注射5 mg ICG（2.5 mg/mL）；Vidal Fortuny评分（0/1/2）。参数：注射时间（tinj）、荧光出现时间（tf）和ICG评估窗口（tev，从注射到评分记录及手术恢复）。
结果： 手术时间（tOR）：88.6 ± 30.2分钟。荧光出现时间（tf）：37.5 ± 5.2秒。ICG评估窗口（tev）：总体6.4 ± 2.3分钟；标准病例5.2 ± 1.8分钟 vs 复杂病例7.8 ± 2.0分钟（p<0.05）。前21例 vs 后21例：tev 7.7 vs 5.1分钟（D = -2.6分钟；p<0.05）。8/42例（19.0%）重新注射。灌注评分：64.3%评分2，32.1%评分1，3.6%评分0。零不良反应，零永久性喉返神经麻痹。
结论： 在本系列中，使用Karl Storz IMAGE1 S™ Rubina®系统的NIR/ICG成像被证明可行且安全。tev参数（平均6.4分钟）客观量化了评估效率，并反映了术者在15-20例后技术的巩固。四个记录的判读陷阱和重新注射方案（19.0%）可为实施该技术的中心提供可复制的技术框架。

英文摘要

BACKGROUND: Postoperative hypoparathyroidism remains the most frequent complication of total thyroidectomy (20-40% transient, 1-4% permanent). Intraoperative NIR imaging with indocyanine green (ICG) is validated for parathyroid gland (PG) perfusion assessment - recognized in the EAES 2023 consensus - but data on practical implementation, temporal parameters and interpretation pitfalls remain limited.
AIM: To describe the ICG technical protocol with the Karl Storz IMAGE1 S™ Rubina® system, to quantify the evaluation window (tev) and to systematize the interpretation pitfalls encountered.
MATERIALS AND METHODS: Prospective, observational, single-centre study (retrospective analysis of prospectively collected data; enrolment dependent on the intraoperative availability of the ICG preparation, therefore not strictly consecutive), including 42 cases in which intraoperative ICG was used during thyroid surgery (37 women, 5 men; mean age 52.6 years; BMI 27.5 kg/m²), performed between February 2024 and February 2025. Uniform protocol: 5 mg ICG IV (2.5 mg/mL) at approximately 66% of the estimated skin-to-skin time; Vidal Fortuny score (0/1/2). Parameters: time of injection (tinj), fluorescence onset (tf) and ICG evaluation window (tev, from injection to score notation and resumption of surgery).
RESULTS: Operative time (tOR): 88.6 +- 30.2 min. Fluorescence onset (tf): 37.5 +- 5.2 sec. ICG evaluation window (tev): 6.4 +- 2.3 min overall; 5.2 +- 1.8 min in standard cases vs 7.8 +- 2.0 min in complex cases (p<0.05). First 21 vs last 21 cases: tev 7.7 vs 5.1 min (D = - 2.6 min; p<0.05). Re-injection in 8/42 cases (19.0%). Perfusion scores: 64.3% score 2, 32.1% score 1, 3.6% score 0. Zero adverse reactions, zero permanent recurrent laryngeal nerve palsy.
CONCLUSIONS: In this series, NIR/ICG imaging with the Karl Storz IMAGE1 S™ Rubina® system proved feasible and safe. The tev parameter (mean 6.4 min) objectively quantifies the efficiency of the assessment and reflects consolidation of the operator's technique after 15 20 cases. The four documented interpretation pitfalls and the re-injection protocol (19.0%) may provide a replicable technical framework for centres implementing this technology.