PDF(Pubmed)
Abstract：
OBJECTIVE: A definitive diagnosis of gastroesophageal reflux disease (GERD) depends on endoscopic and/or pH-study criteria. However, high resolution manometry (HRM) can identify factors predicting GERD, such as ineffective esophageal motility (IEM), esophago-gastric junction contractile integral (EGJ-CI), evaluating esophagogastric junction (EGJ) type and straight leg raise (SLR) maneuver response. We aimed to build and externally validate a manometric score (Milan Score) to stratify the risk and severity of the disease in patients undergoing HRM for suspected GERD.
METHODS: A population of 295 consecutive patients undergoing HRM and pH-study for persistent typical or atypical GERD symptoms was prospectively enrolled to build a model and a nomogram that provides a risk score for AET > 6%. Collected HRM data included IEM, EGJ-CI, EGJ type and SLR. A supplemental cohort of patients undergoing HRM and pH-study was also prospectively enrolled in 13 high-volume esophageal function laboratories across the world in order to validate the model. Discrimination and calibration were used to assess model\'s accuracy. Gastroesophageal reflux disease was defined as acid exposure time >6%.
RESULTS: Out of the analyzed variables, SLR response and EGJ subtype 3 had the highest impact on the score (odd ratio 18.20 and 3.87, respectively). The external validation cohort consisted of 233 patients. In the validation model, the corrected Harrel c-index was 0.90. The model-fitting optimism adjusted calibration slope was 0.93 and the integrated calibration index was 0.07, indicating good calibration.
CONCLUSIONS: A novel HRM score for GERD diagnosis has been created and validated. The MS might be a useful screening tool to stratify the risk and the severity of GERD, allowing a more comprehensive pathophysiologic assessment of the anti-reflux barrier.
BACKGROUND: ClinicalTrials.gov (Identifier: NCT05851482).
METHODS: A population of 295 consecutive patients undergoing HRM and pH-study for persistent typical or atypical GERD symptoms was prospectively enrolled to build a model and a nomogram that provides a risk score for AET > 6%. Collected HRM data included IEM, EGJ-CI, EGJ type and SLR. A supplemental cohort of patients undergoing HRM and pH-study was also prospectively enrolled in 13 high-volume esophageal function laboratories across the world in order to validate the model. Discrimination and calibration were used to assess model\'s accuracy. Gastroesophageal reflux disease was defined as acid exposure time >6%.
RESULTS: Out of the analyzed variables, SLR response and EGJ subtype 3 had the highest impact on the score (odd ratio 18.20 and 3.87, respectively). The external validation cohort consisted of 233 patients. In the validation model, the corrected Harrel c-index was 0.90. The model-fitting optimism adjusted calibration slope was 0.93 and the integrated calibration index was 0.07, indicating good calibration.
CONCLUSIONS: A novel HRM score for GERD diagnosis has been created and validated. The MS might be a useful screening tool to stratify the risk and the severity of GERD, allowing a more comprehensive pathophysiologic assessment of the anti-reflux barrier.
BACKGROUND: ClinicalTrials.gov (Identifier: NCT05851482).
摘要：
目的：胃食管反流病（GERD）的明确诊断取决于内镜和/或pH研究标准。然而,高分辨率测压(HRM)可以识别预测GERD的因素，如无效食管运动(IEM)，食管-胃交界处收缩积分（EGJ-CI），评估食管胃结合部（EGJ）类型和直腿抬高（SLR）动作反应。我们旨在建立并外部验证测压评分（米兰评分），以对因疑似GERD而接受HRM的患者的疾病风险和严重程度进行分层。
方法：前瞻性招募了295名接受HRM和pH研究的持续典型或非典型GERD症状的连续患者，以建立模型和列线图，提供AET>6％的风险评分。收集的HRM数据包括IEM，EGJ-CI、EGJ型和SLR。为了验证该模型，还前瞻性地在世界各地的13个高容量食管功能实验室中招募了接受HRM和pH研究的患者补充队列。鉴别和校准用于评估模型的准确性。胃食管反流病定义为酸暴露时间>6%。
结果：在分析的变量中，SLR反应和EGJ亚型3对评分的影响最大（奇数比分别为18.20和3.87）。外部验证队列由233名患者组成。在验证模型中，校正后的Harrelc指数为0.90。模型拟合乐观调整后的校准斜率为0.93，综合校准指数为0.07，表明校准效果良好。
结论：已创建并验证了GERD诊断的新HRM评分。MS可能是对GERD的风险和严重程度进行分层的有用筛查工具，允许对抗反流屏障进行更全面的病理生理评估。
背景：ClinicalTrials.gov（标识符：NCT05851482）。
方法：前瞻性招募了295名接受HRM和pH研究的持续典型或非典型GERD症状的连续患者，以建立模型和列线图，提供AET>6％的风险评分。收集的HRM数据包括IEM，EGJ-CI、EGJ型和SLR。为了验证该模型，还前瞻性地在世界各地的13个高容量食管功能实验室中招募了接受HRM和pH研究的患者补充队列。鉴别和校准用于评估模型的准确性。胃食管反流病定义为酸暴露时间>6%。
结果：在分析的变量中，SLR反应和EGJ亚型3对评分的影响最大（奇数比分别为18.20和3.87）。外部验证队列由233名患者组成。在验证模型中，校正后的Harrelc指数为0.90。模型拟合乐观调整后的校准斜率为0.93，综合校准指数为0.07，表明校准效果良好。
结论：已创建并验证了GERD诊断的新HRM评分。MS可能是对GERD的风险和严重程度进行分层的有用筛查工具，允许对抗反流屏障进行更全面的病理生理评估。
背景：ClinicalTrials.gov（标识符：NCT05851482）。
