Clinical trial NCT05851482: Validation of HRM Score for the GERD Diagnosis
Official title: NOVEL HIGH-RESOLUTION MANOMETRY SCORE FOR THE DIAGNOSIS OF GASTRO-ESOPHAGEAL REFLUX DISEASE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro Esophageal Reflux
Keywords: High Resolution Manometry
Gastroesophageal reflux disease
Esophagogastric junction
Inta-abdominal pressure
Straight leg raise maneuver
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
Collaborators: name: University of Milan
name: Medical University of Vienna
name: Washington University School of Medicine
name: University of Pisa
name: Swedish Medical Center
name: Hospital Universiti Sains Malaysia
name: University of Campania Luigi Vanvitelli
name: Universita degli Studi di Genova
name: Jikei University School of Medicine
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: University of Athens
First posted: 2023-05-09
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective descriptive study
Primary purpose: DIAGNOSTIC

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%).

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

Primary outcomes:
measure: HRM score
timeFrame: From date of inclusion in the study until the diagnosis of GERD, up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan
Study officials:
affiliation: IRCCS Policlinico S. Donato
name: Stefano Siboni, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.