Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
246 participants
INTERVENTIONAL
2022-12-01
2023-04-29
Brief Summary
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Is it possible to predict GERD on high resolution manometry? Participants will be asked to undergo high resolution manometry and pH-study
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Detailed Description
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In this multicenter international prospective study, we aimed to build a score to predict pathological esophageal acid exposure time (AET\>6%).
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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GERD
Patients with GERD symptoms
High resolution manometry
Standard chicago classification 4.0 HRM protocol
Interventions
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High resolution manometry
Standard chicago classification 4.0 HRM protocol
Eligibility Criteria
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Inclusion Criteria
* SLR maneuver performed at the end of HRM
Exclusion Criteria
* prior esophageal surgery
* paraesophageal hiatal hernia
* eosinophilic esophagitis
* scleroderma
* esophageal achalasia
18 Years
75 Years
ALL
No
Sponsors
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University of Milan
OTHER
Medical University of Vienna
OTHER
Washington University School of Medicine
OTHER
University of Pisa
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
IRCCS Policlinico S. Donato
OTHER
Responsible Party
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Stefano Siboni
Medical Doctor
Principal Investigators
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Stefano Siboni, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Policlinico S. Donato
Locations
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IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy
Countries
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References
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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.
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.
Other Identifiers
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HRM Nomogram GERD
Identifier Type: -
Identifier Source: org_study_id
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