Validation of HRM Score for the GERD Diagnosis

Not Applicable

Completed

• Conditions: Gastro Esophageal Reflux
• Interventions: Diagnostic Test: High resolution manometry

• Registration Number: NCT05851482
• Lead Sponsor: IRCCS Policlinico S. Donato

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%).

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-04-29
• Study First Submitted: 2023-04-29
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-08
• Last Update Submitted: 2023-05-08
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GERD	High resolution manometry	Patients with GERD symptoms

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milan, Italy