Validation of HRM Score for the GERD Diagnosis (HRM nomogram)
Primary Purpose
Gastro Esophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High resolution manometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastro Esophageal Reflux focused on measuring High Resolution Manometry, Gastroesophageal reflux disease, Esophagogastric junction, Inta-abdominal pressure, Straight leg raise maneuver
Eligibility Criteria
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
Sites / Locations
- IRCCS Policlinico San Donato
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GERD
Arm Description
Patients with GERD symptoms
Outcomes
Primary Outcome Measures
HRM score
HRM score is based on EJG type, ineffective esophageal motility, straight leg raise maneuver and EGJ contractile integral
Secondary Outcome Measures
Full Information
NCT ID
NCT05851482
First Posted
April 29, 2023
Last Updated
May 8, 2023
Sponsor
IRCCS Policlinico S. Donato
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT05851482
Brief Title
Validation of HRM Score for the GERD Diagnosis
Acronym
HRM nomogram
Official Title
NOVEL HIGH-RESOLUTION MANOMETRY SCORE FOR THE DIAGNOSIS OF GASTRO-ESOPHAGEAL REFLUX DISEASE
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
April 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Donato
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux
Keywords
High Resolution Manometry, Gastroesophageal reflux disease, Esophagogastric junction, Inta-abdominal pressure, Straight leg raise maneuver
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective descriptive study
Masking
None (Open Label)
Allocation
N/A
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GERD
Arm Type
Experimental
Arm Description
Patients with GERD symptoms
Intervention Type
Diagnostic Test
Intervention Name(s)
High resolution manometry
Intervention Description
Standard chicago classification 4.0 HRM protocol
Primary Outcome Measure Information:
Title
HRM score
Description
HRM score is based on EJG type, ineffective esophageal motility, straight leg raise maneuver and EGJ contractile integral
Time Frame
From date of inclusion in the study until the diagnosis of GERD, up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Siboni, MD
Organizational Affiliation
IRCCS Policlinico S. Donato
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
Milan
ZIP/Postal Code
20097
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36270615
Citation
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. 2023 Jul;21(7):1761-1770.e1. doi: 10.1016/j.cgh.2022.10.008. Epub 2022 Oct 19.
Results Reference
background
Learn more about this trial
Validation of HRM Score for the GERD Diagnosis
We'll reach out to this number within 24 hrs