Surgical endoscopy · 2026
Near-infrared fluorescence imaging for intraoperative identification of thoracic sympathetic ganglia during VATS ganglionectomy: a randomized controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Rim Gongmin, Kim Jae Jun, Hyun Kwanyong, Lee Jungsun, Cho Hyunmi
Аннотация
BACKGROUND/PURPOSE: Facial blushing and craniofacial hyperhidrosis are sympathetically mediated disorders that may require surgical treatment. Rib-oriented thoracic sympathicotomy provides standardized landmarks but does not directly identify the target ganglion, whose position varies among individuals. This randomized controlled trial evaluated whether near-infrared fluorescence imaging with indocyanine green (NIR-ICG) improves the anatomical identification of the T2 sympathetic ganglion during video-assisted thoracoscopic (VATS) T2/5 ganglionectomy; the trial was not designed to test clinical superiority.
METHODS: Forty-three patients underwent bilateral VATS T2/5 ganglionectomy with (NIR group, n = 22) or without (conventional group, n = 21) NIR-ICG imaging. The prespecified primary endpoint was an anatomical localization endpoint: histopathological confirmation of sympathetic ganglion tissue resected from the T2 level, with the level confirmed by intraoperative clip placement and postoperative chest radiography. Clinical outcomes (symptom resolution, compensatory hyperhidrosis [CH], length of hospital stay, and 1-year recurrence) were prespecified as exploratory; the trial was not powered for between-group clinical comparison.
RESULTS: T2 ganglion confirmation was achieved in 22/22 NIR patients (100%; 95% Wilson CI 85.1-100%) and 18/21 conventional patients (85.7%; 95% Wilson CI 65.4-95.0%); the absolute difference was 14.3 percentage points (95% Newcombe-Wilson CI - 3.3 to 34.6; p = 0.042). Short-term clinical outcomes were similar: facial blushing "almost disappeared" in 76.4 vs. 68.4%; CH occurred in 63.6 vs. 61.9% (moderate-to-severe 1 vs. 2); hospital stay was 1 day in both; no recurrence at 1 year. No major complications occurred.
CONCLUSION: Within a T2/5 ganglionectomy protocol, NIR-ICG fluorescence imaging improved the anatomical identification of the T2 sympathetic ganglion. As the trial was powered for this anatomical endpoint, not clinical superiority, the similar short-term clinical outcomes should be interpreted as reflecting limited statistical resolution rather than as evidence of clinical equivalence. Whether enhanced anatomical precision translates into clinically meaningful benefit requires adequately powered, longer-term studies.
METHODS: Forty-three patients underwent bilateral VATS T2/5 ganglionectomy with (NIR group, n = 22) or without (conventional group, n = 21) NIR-ICG imaging. The prespecified primary endpoint was an anatomical localization endpoint: histopathological confirmation of sympathetic ganglion tissue resected from the T2 level, with the level confirmed by intraoperative clip placement and postoperative chest radiography. Clinical outcomes (symptom resolution, compensatory hyperhidrosis [CH], length of hospital stay, and 1-year recurrence) were prespecified as exploratory; the trial was not powered for between-group clinical comparison.
RESULTS: T2 ganglion confirmation was achieved in 22/22 NIR patients (100%; 95% Wilson CI 85.1-100%) and 18/21 conventional patients (85.7%; 95% Wilson CI 65.4-95.0%); the absolute difference was 14.3 percentage points (95% Newcombe-Wilson CI - 3.3 to 34.6; p = 0.042). Short-term clinical outcomes were similar: facial blushing "almost disappeared" in 76.4 vs. 68.4%; CH occurred in 63.6 vs. 61.9% (moderate-to-severe 1 vs. 2); hospital stay was 1 day in both; no recurrence at 1 year. No major complications occurred.
CONCLUSION: Within a T2/5 ganglionectomy protocol, NIR-ICG fluorescence imaging improved the anatomical identification of the T2 sympathetic ganglion. As the trial was powered for this anatomical endpoint, not clinical superiority, the similar short-term clinical outcomes should be interpreted as reflecting limited statistical resolution rather than as evidence of clinical equivalence. Whether enhanced anatomical precision translates into clinically meaningful benefit requires adequately powered, longer-term studies.