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

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

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

Study Overview

• Status: Completed
• Conditions: Gastro Esophageal Reflux
• Intervention / Treatment: Diagnostic test: High resolution manometry

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 Type: Interventional
• Enrollment (Actual): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan
    • San Donato Milanese, Milan, Italy, 20097
      • IRCCS Policlinico San Donato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GERD; Patients with GERD symptoms	Diagnostic test: High resolution manometry; Standard chicago classification 4.0 HRM protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HRM score	HRM score is based on EJG type, ineffective esophageal motility, straight leg raise maneuver and EGJ contractile integral	From date of inclusion in the study until the diagnosis of GERD, up to 2 months

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato
• Collaborators: University of Pisa; Medical University of Vienna; Washington University School of Medicine; University of Campania "Luigi Vanvitelli"; University of Athens; Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Hospital Universiti Sains Malaysia; Universita degli Studi di Genova; University of Milan; Swedish Medical Center; Jikei University School of Medicine
• Investigators: Principal Investigator: Stefano Siboni, MD, IRCCS Policlinico S. Donato

Publications and helpful links

General Publications

• Siboni S, Kristo I, Rogers BD, De Bortoli N, Hobson A, Louie B, Lee YY, Tee V, Tolone S, Marabotto E, Visaggi P, Haworth J, Ivy M, Greenan G, Facchini C, Masuda T, Yano F, Perry K, Balasubramanian G, Theodorou D, Triantafyllou T, Cusmai L, Boveri S, Schoppmann SF, Gyawali CP, Bonavina L. Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The "Straight Leg-Raise" International Study. Clin Gastroenterol Hepatol. 2022 Oct 19:S1542-3565(22)00970-3. doi: 10.1016/j.cgh.2022.10.008. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): April 29, 2023

Study Registration Dates

• First Submitted: April 29, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Gastroesophageal reflux disease; High Resolution Manometry; Esophagogastric junction; Inta-abdominal pressure; Straight leg raise maneuver
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: HRM Nomogram GERD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No