Skip to main content
OpenTrials
Completed

NCT Number: NCT05851482

Validation of HRM Score for the GERD Diagnosis

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High resolution manometry

Diagnostic Test

Standard chicago classification 4.0 HRM protocol

Primary outcomes

  1. HRM score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HRM nomogram

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 9, 2023
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.