Validation of HRM Score for the GERD Diagnosis

Gastro Esophageal Reflux Clinical Trial

— HRM nomogram  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05851482
• Other study ID #: HRM Nomogram GERD
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: April 29, 2023

Study information

• Verified date: May 2023
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: April 29, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

Diagnostic Test:
• High resolution manometry
Standard chicago classification 4.0 HRM protocol

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Milan

Sponsors (12)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato	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

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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