Validation of HRM Score for the GERD Diagnosis

Study Overview
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Brief Summary
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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

Detailed Description
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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%).

Official Title
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NOVEL HIGH-RESOLUTION MANOMETRY SCORE FOR THE DIAGNOSIS OF GASTRO-ESOPHAGEAL REFLUX DISEASE

Conditions
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Gastro Esophageal Reflux

Intervention / Treatment
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* Diagnostic Test: High resolution manometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HRM and wireless pH-study or catheter pH-impedance study performed for persistent GERD symptoms off proton-pump inhibitor (PPI) within two weeks of each other, SLR maneuver performed at the end of HRM Exclusion Criteria: Body mass index (BMI) >35 Kg/m2 prior esophageal surgery paraesophageal hiatal hernia eosinophilic esophagitis scleroderma esophageal achalasia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective descriptive study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GERD<br>Patients with GERD symptoms | Diagnostic Test: High resolution manometry<br>* Standard chicago classification 4.0 HRM protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal reflux disease, Esophagogastric junction, High Resolution Manometry, Inta-abdominal pressure, Straight leg raise maneuver