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Validation of the Milan Score Using Prolonged Wireless PH Monitoring.

Stefano Siboni1, Jiurgen Mema1, Trevor McCarthy2

  • 1Division of General and Emergency Surgery, IRCCS Policlinico San Donato, University of Milan, Milano, Italy.

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Summary
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The Milan Score effectively predicts pathologic gastroesophageal reflux disease (GERD) using 96-hour wireless pH-monitoring, offering a reliable diagnostic tool. This validation confirms its utility in GERD assessment.

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Area of Science:

  • Gastroenterology
  • Diagnostic Medicine
  • Esophageal Physiology

Background:

  • The Milan Score, a novel high-resolution manometry (HRM) metric, quantifies anti-reflux barrier disruption and estimates pathologic gastroesophageal reflux disease (GERD) probability.
  • Previous validations relied on 24-hour pH-impedance, susceptible to day-to-day variability; this study aimed to validate the Milan Score using longer 96-hour wireless pH-monitoring.

Purpose of the Study:

  • To validate the effectiveness of the Milan Score in predicting GERD using 96-hour wireless pH-monitoring.
  • To assess the Milan Score's diagnostic performance against established GERD criteria.

Main Methods:

  • Retrospective collection of data from adult GERD patients undergoing HRM and 96-hour wireless pH-monitoring.
  • Automatic calculation of the Milan Score from HRM metrics and pH monitoring according to Lyon Consensus 2.0 criteria.
  • Evaluation of diagnostic performance using receiver operator characteristics (ROC) analysis.

Main Results:

  • Among 90 patients, 48 had conclusive GERD. Hiatal hernia prevalence and SLR-induced pressure increase were higher in GERD patients.
  • A positive Milan Score was found in 65% of GERD patients versus 19% of non-GERD patients (p < 0.001).
  • ROC analysis yielded an AUC of 0.812 for conclusive GERD, with a sensitivity of 60.4% and specificity of 92.9% at the optimal threshold.

Conclusions:

  • The Milan Score reliably predicts pathologic reflux based on 96-hour wireless pH-monitoring, aligning with Lyon Consensus 2.0 criteria.
  • The Milan Score demonstrates diagnostic performance comparable to 24-hour pH-impedance studies.
  • This validation strengthens the evidence for the Milan Score's utility in GERD diagnosis.