Gastro Esophageal Reflux
Conditions
Keywords
High Resolution Manometry, Gastroesophageal reflux disease, Esophagogastric junction, Inta-abdominal pressure, Straight leg raise maneuver
Brief summary
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
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%).
Interventions
Standard chicago classification 4.0 HRM protocol
Sponsors
Study design
Intervention model description
Prospective descriptive study
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HRM score | From date of inclusion in the study until the diagnosis of GERD, up to 2 months | HRM score is based on EJG type, ineffective esophageal motility, straight leg raise maneuver and EGJ contractile integral |
Countries
Italy