HRM nomogram: Validation of HRM Score for the GERD Diagnosis

• Sponsor: IRCCS Policlinico S. Donato (Other)
• Overall Status: Completed
• CT.gov ID: NCT05851482
• Collaborator: University of Milan (Other), Medical University of Vienna (Other), Washington University School of Medicine (Other), University of Pisa (Other), Swedish Medical Center (Other), Hospital Universiti Sains Malaysia (Other), University of Campania "Luigi Vanvitelli" (Other), Universita degli Studi di Genova (Other), Jikei University School of Medicine (Other), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other), University of Athens (Other)
• Enrollment: 246
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.9
• Patients Per Site Per Month: 50.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastro Esophageal Reflux	Diagnostic Test: High resolution manometry	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 246 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective descriptive studyProspective descriptive study
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: NOVEL HIGH-RESOLUTION MANOMETRY SCORE FOR THE DIAGNOSIS OF GASTRO-ESOPHAGEAL REFLUX DISEASE
• Actual Study Start Date: Dec 1, 2022
• Actual Primary Completion Date: Feb 28, 2023
• Actual Study Completion Date: Apr 29, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Policlinico San Donato	San Donato Milanese	Milan	Italy	20097

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Stefano Siboni, MD, IRCCS Policlinico S. Donato

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Stefano Siboni, Medical Doctor, IRCCS Policlinico S. Donato
• ClinicalTrials.gov Identifier: NCT05851482
• Other Study ID Numbers: HRM Nomogram GERD
• First Posted: May 9, 2023
• Last Update Posted: May 9, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stefano Siboni, Medical Doctor, IRCCS Policlinico S. Donato: High Resolution Manometry; Gastroesophageal reflux disease; Esophagogastric junction; Inta-abdominal pressure; Straight leg raise maneuver
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic

Study Results

No Results Posted as of May 9, 2023