Liver international : official journal of the International Association for the Study of the Liver · 2025
Indocyanine Green Clearance Test via Pulse Dye Densitometry for Portal Hypertension Diagnosis in cACLD.
СтатьяНаблюдательное исследованиеВалидационное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Liu Miaoxia, Zhang Xiaofeng, Cheng Xiao, He Qinjun, Zhou Tiantian, Wang Haiyu, Li Beiling, Luo Wenfan, Li Junying, Li Hui, Lin Zimo, Song Jiankang, Wang Weibin, Huang Jing, Ji Yali, Zhou Damei, Xie Wanjun, Yang Qiaolan, Tu Minghan, Luo Xiaoqin, Zhang Xiaoyong, Yan Huadong, Chen Jinjun
Аннотация
BACKGROUND AND AIMS: Performance of pulse dye densitometry (PDD)-estimated indocyanine green 15-min retention rate (ICG-R15) in the diagnosis of clinically significant portal hypertension (CSPH) has not been studied. A prospective compensated advanced chronic liver disease (cACLD) cohort was used to explore the capability of ICG-R15 in the differentiation of CSPH as referenced by hepatic venous pressure gradient (HVPG).
PATIENTS AND METHODS: Performance of ICG-R15 alone and combined with Baveno VII algorithm for CSPH differentiation was established with a monocentric set and validated with a bicentric set of patients with HVPG assessment.
RESULTS: In the training set (n = 96), ICG-R15 ≥ 14% could identify 63.6% (28/44) CSPH with 96.2% specificity and 93.3% positive predictive value (PPV). ICG-R15 < 4% was able to exclude 40.4% (21/52) non-CSPH with 95.5% sensitivity and 91.3% negative predictive value (NPV). In the validation set (n = 106), ICG-R15 ≥ 14% could identify 63.6% (28/44) CSPH with 95.2% specificity and 90.3% PPV. ICG-R15 < 4% could exclude 41.9% (26/62) non-CSPH with 95.5% sensitivity and 92.9% NPV. Sensitivity analysis in the total set of patients (n = 202) reinforced robustness. Combined ICG-R15 ≥ 14% with LSM ≥ 25 kPa improved performance with 72.7% (64/88) sensitivity, 85.3% PPV and 90.4% specificity. Meanwhile, ICG-R15 < 4% with LSM ≤ 15 kPa plus platelet count ≥ 150 × 109/L excluded CSPH with 95.5% sensitivity and 94.5% NPV, reducing diagnosis uncertainty (grey zone) to 26.7%.
CONCLUSION: PDD-estimated ICG-R15 ≥ 14% could identify CSPH and ICG-R15 < 4% to exclude CSPH in cACLD patients. ICG-R15 sequential with Baveno VII enhanced diagnostic capability, warranting multicentre validation.
TRIAL REGISTRATION: NCT04123509, NCT04820166 and NCT05251272.
PATIENTS AND METHODS: Performance of ICG-R15 alone and combined with Baveno VII algorithm for CSPH differentiation was established with a monocentric set and validated with a bicentric set of patients with HVPG assessment.
RESULTS: In the training set (n = 96), ICG-R15 ≥ 14% could identify 63.6% (28/44) CSPH with 96.2% specificity and 93.3% positive predictive value (PPV). ICG-R15 < 4% was able to exclude 40.4% (21/52) non-CSPH with 95.5% sensitivity and 91.3% negative predictive value (NPV). In the validation set (n = 106), ICG-R15 ≥ 14% could identify 63.6% (28/44) CSPH with 95.2% specificity and 90.3% PPV. ICG-R15 < 4% could exclude 41.9% (26/62) non-CSPH with 95.5% sensitivity and 92.9% NPV. Sensitivity analysis in the total set of patients (n = 202) reinforced robustness. Combined ICG-R15 ≥ 14% with LSM ≥ 25 kPa improved performance with 72.7% (64/88) sensitivity, 85.3% PPV and 90.4% specificity. Meanwhile, ICG-R15 < 4% with LSM ≤ 15 kPa plus platelet count ≥ 150 × 109/L excluded CSPH with 95.5% sensitivity and 94.5% NPV, reducing diagnosis uncertainty (grey zone) to 26.7%.
CONCLUSION: PDD-estimated ICG-R15 ≥ 14% could identify CSPH and ICG-R15 < 4% to exclude CSPH in cACLD patients. ICG-R15 sequential with Baveno VII enhanced diagnostic capability, warranting multicentre validation.
TRIAL REGISTRATION: NCT04123509, NCT04820166 and NCT05251272.