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| Name | Class |
|---|---|
| University of Milan | OTHER |
| Medical University of Vienna | OTHER |
| Washington University School of Medicine | OTHER |
| University of Pisa |
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The goal of this prospective study is to validate a high resolution manometry score to predict pathologic GERD in patients with reflux symptoms. The main question it aims to answer is:
Is it possible to predict GERD on high resolution manometry? Participants will be asked to undergo high resolution manometry and pH-study
According to recent guidelines, high resolution manometry (HRM) has an ancillary role in the diagnosis of gastro-esophageal reflux disease (GERD). A recent multicenter study demonstrated the effectiveness of the straight leg raise (SLR) maneuver in predicting GERD, thus increasing the diagnostic value of HRM in patients with suspected pathological reflux. HRM parameters associated with GERD include esophageal body hypomotility such as ineffective esophageal motility (IEM), and esophagogastric junction (EGJ) metrics, particularly the EGJ contractile integral (EGJ-CI) that takes into consideration the presence or absence of a hiatal hernia (HH), and a hypotensive lower esophageal sphincter (LES). The combination of these four parameters might help to predict or exclude true GERD in patients undergoing HRM with the suspicion of GERD.
In this multicenter international prospective study, we aimed to build a score to predict pathological esophageal acid exposure time (AET>6%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GERD | Experimental | Patients with GERD symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High resolution manometry | Diagnostic Test | Standard chicago classification 4.0 HRM protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| HRM score | HRM score is based on EJG type, ineffective esophageal motility, straight leg raise maneuver and EGJ contractile integral | From date of inclusion in the study until the diagnosis of GERD, up to 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Siboni, MD | IRCCS Policlinico S. Donato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Donato | San Donato Milanese | Milan | 20097 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36270615 | Background | Siboni S, Kristo I, Rogers BD, De Bortoli N, Hobson A, Louie B, Lee YY, Tee V, Tolone S, Marabotto E, Visaggi P, Haworth J, Ivy M, Greenan G, Facchini C, Masuda T, Yano F, Perry K, Balasubramanian G, Theodorou D, Triantafyllou T, Cusmai L, Boveri S, Schoppmann SF, Gyawali CP, Bonavina L. Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The "Straight Leg-Raise" International Study. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1761-1770.e1. doi: 10.1016/j.cgh.2022.10.008. Epub 2022 Oct 19. | |
| 38536701 |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| OTHER |
| Swedish Medical Center | OTHER |
| Hospital Universiti Sains Malaysia | OTHER |
| University of Campania Luigi Vanvitelli | OTHER |
| Universita degli Studi di Genova | OTHER |
| Jikei University School of Medicine | OTHER |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | OTHER |
| University of Athens | OTHER |
Prospective descriptive study
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| Derived |
| Siboni S, Sozzi M, Kristo I, Boveri S, Rogers BD, De Bortoli N, Hobson A, Louie BE, Lee YY, Tolone S, Marabotto E, Visaggi P, Haworth J, Ivy ML, Greenan G, Masuda T, Penagini R, Barcella B, Coletta M, Theodorou D, Triantafyllou T, Facchini C, Tee V, Bonavina L, Cusmai L, Schoppmann SF, Savarino E, Asti E, Gyawali CP. The Milan score: A novel manometric tool for a more efficient diagnosis of gastro-esophageal reflux disease. United European Gastroenterol J. 2024 Jun;12(5):552-561. doi: 10.1002/ueg2.12565. Epub 2024 Mar 27. |
| D004066 | Digestive System Diseases |