Validation of HRM Score for the GERD Diagnosis (HRM nomogram)

San Donato Group (GSD)

Status: Completed

Conditions: Gastro Esophageal Reflux

Treatments: Diagnostic Test: High resolution manometry

Study type: Interventional

Funder types: Other

Identifiers

NCT05851482

HRM Nomogram GERD

Details and patient eligibility

About

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

Full 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%).

Enrollment: 246 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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246 participants in 1 patient group

GERD

Experimental group

Description:

Patients with GERD symptoms

Treatment:

Diagnostic Test: High resolution manometry