Annals of medicine · 2026
Development and validation of a rapid 15-minute gastric ultrasound protocol for suspected gastroparesis: a prospective diagnostic accuracy study.
СтатьяВалидационное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Wang Zheyu, Ma Mengxi, Wu Xia, Xu Xiaofei, Xu Xiaoshuang, Cui Bota, Wen Quan, Lv Kangtai, Wang Juan, Zhang Faming
Аннотация
BACKGROUND: Gastric emptying scintigraphy (GES) is the reference standard for gastroparesis but is limited by time, cost, and accessibility. We aimed to validate a practical 15-minute gastric ultrasonography (GUS) threshold for early assessment of suspected gastroparesis.
MATERIALS AND METHODS: We conducted a prospective diagnostic accuracy study comparing GUS with GES. Participants were divided into training and validation cohorts by enrollment date. Using 4-hour GES as reference, the optimal GUS cut-off was derived by ROC analysis in the training cohort and tested in the validation cohort. Reproducibility and associations with symptom severity were assessed.
RESULTS: Of 123 participants screened, 113 completed both GUS and GES (training, n = 67; validation, n = 46). GUS15min correlated with GES-derived emptying rates (GES120min: r = 0.51; GES240min: r = 0.50; both p < 0.0001). The optimal training cut-off was 0.195 (AUC 0.91, 95%CI 0.81-1.00). In validation, a threshold of 0.200 yielded an AUC of 0.90 (95%CI 0.80-0.99), sensitivity of 93.2%, and specificity of 88.3%, with substantial agreement with GES240min (κ = 0.758). Reproducibility was excellent (ICC = 0.976; κ = 0.904). GUS had a higher completion rate than GES (99.2% vs. 93.4%, p = 0.039). GUS15min was more strongly associated with total GCSI score than GES240min (r = -0.52 vs. -0.29; p = 0.0001).
CONCLUSIONS: A GUS15min threshold < 20.0% showed good validation performance, excellent reproducibility, and higher completion than GES. GUS may provide a useful bedside screening approach for suspected gastroparesis and help identify patients who should proceed to GES.
MATERIALS AND METHODS: We conducted a prospective diagnostic accuracy study comparing GUS with GES. Participants were divided into training and validation cohorts by enrollment date. Using 4-hour GES as reference, the optimal GUS cut-off was derived by ROC analysis in the training cohort and tested in the validation cohort. Reproducibility and associations with symptom severity were assessed.
RESULTS: Of 123 participants screened, 113 completed both GUS and GES (training, n = 67; validation, n = 46). GUS15min correlated with GES-derived emptying rates (GES120min: r = 0.51; GES240min: r = 0.50; both p < 0.0001). The optimal training cut-off was 0.195 (AUC 0.91, 95%CI 0.81-1.00). In validation, a threshold of 0.200 yielded an AUC of 0.90 (95%CI 0.80-0.99), sensitivity of 93.2%, and specificity of 88.3%, with substantial agreement with GES240min (κ = 0.758). Reproducibility was excellent (ICC = 0.976; κ = 0.904). GUS had a higher completion rate than GES (99.2% vs. 93.4%, p = 0.039). GUS15min was more strongly associated with total GCSI score than GES240min (r = -0.52 vs. -0.29; p = 0.0001).
CONCLUSIONS: A GUS15min threshold < 20.0% showed good validation performance, excellent reproducibility, and higher completion than GES. GUS may provide a useful bedside screening approach for suspected gastroparesis and help identify patients who should proceed to GES.