The Milan score: A novel manometric tool for a more efficient diagnosis of gastro-esophageal reflux disease

Siboni S 1 , Sozzi M 1 , Kristo I 2 , Boveri S 3 , Rogers BD 4 , De Bortoli N 5 Show all authors , Hobson A 6 , Louie BE 7 , Lee YY 8 , Tolone S 9 , Marabotto E 10 , Visaggi P 5 , Haworth J 6 , Ivy ML 7 , Greenan G 4 , Masuda T 11 , Penagini R 12 , Barcella B 1 , Coletta M 12 , Theodorou D 13 , Triantafyllou T 13 , Facchini C 10 , Tee V 8 , Bonavina L 14 , Cusmai L 1 , Schoppmann SF 2 , Savarino E 15 , Asti E 1 , Gyawali CP 4

Affiliations 

  • 1 Division of General and Emergency Surgery, IRCCS Policlinico San Donato, Milano, Italy
  • 2 Upper-GI-Service, Medizinische Universität, Wien, Austria
  • 3 Laboratory of Biostatistics and Data Management, Scientific Directorate, IRCCS Policlinico San Donato, Milano, Italy
  • 4 Division of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri, USA
  • 5 Division of Gastroenterology, University of Pisa, Pisa, Italy
  • 6 The Functional Gut Clinic, London, UK
  • 7 Division of Thoracic Surgery, Swedish Medical Center, Digestive Health Institute, Seattle, Washington, USA
  • 8 School of Medical Sciences and GI Function and Motility Unit, Universiti Sains Malaysia, Kota Bharu, Malaysia
  • 9 Division of General, Mini-Invasive and Bariatric Surgery, University of Naples, Naples, Italy
  • 10 Gastroenterology Unit, IRCCS Policlinico San Martino, Genoa, Italy
  • 11 Department of Surgery, Jikei University School of Medicine, Minato-ku, Japan
  • 12 Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
  • 13 Foregut Surgery Unit, University of Athens School of Medicine, Athens, Greece
  • 14 University of Milan, Milan, Italy
  • 15 Division of Gastroenterology, Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy
United European Gastroenterol J, 2024 Mar 27.
PMID: 38536701 DOI: 10.1002/ueg2.12565

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.

TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT05851482).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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