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Validation of HRM Score for the GERD Diagnosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05851482
Acronym
HRM nomogram
Enrollment
246
Registered
2023-05-09
Start date
2022-12-01
Completion date
2023-04-29
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro Esophageal Reflux

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

University of Milan
CollaboratorOTHER
Medical University of Vienna
CollaboratorOTHER
Washington University School of Medicine
CollaboratorOTHER
University of Pisa
CollaboratorOTHER
Swedish Medical Center
CollaboratorOTHER
Hospital Universiti Sains Malaysia
CollaboratorOTHER
University of Campania Luigi Vanvitelli
CollaboratorOTHER
Universita degli Studi di Genova
CollaboratorOTHER
Jikei University School of Medicine
CollaboratorOTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
CollaboratorOTHER
University of Athens
CollaboratorOTHER
IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Prospective descriptive study

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

MeasureTime frameDescription
HRM scoreFrom date of inclusion in the study until the diagnosis of GERD, up to 2 monthsHRM score is based on EJG type, ineffective esophageal motility, straight leg raise maneuver and EGJ contractile integral

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026