NCT05851482

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

April 29, 2023

Last Update Submit

May 8, 2023

Conditions

Gastro Esophageal Reflux

Keywords

High Resolution ManometryGastroesophageal reflux diseaseEsophagogastric junctionInta-abdominal pressureStraight leg raise maneuver

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

GERD

EXPERIMENTAL

Patients with GERD symptoms

Diagnostic Test: High resolution manometry

Interventions

High resolution manometryDIAGNOSTIC_TEST

Standard chicago classification 4.0 HRM protocol

GERD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Body mass index (BMI) \>35 Kg/m2
  • prior esophageal surgery
  • paraesophageal hiatal hernia
  • eosinophilic esophagitis
  • scleroderma
  • esophageal achalasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Related Publications (2)

  • 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.

    PMID: 36270615BACKGROUND

  • Siboni S, Sozzi M, Kristo I, Boveri S, Rogers BD, De Bortoli N, Hobson A, Louie BE, Lee YY, Tolone S, Marabotto E, Visaggi P, Haworth J, Ivy ML, Greenan G, Masuda T, Penagini R, Barcella B, Coletta M, Theodorou D, Triantafyllou T, Facchini C, Tee V, Bonavina L, Cusmai L, Schoppmann SF, Savarino E, Asti E, Gyawali CP. The Milan score: A novel manometric tool for a more efficient diagnosis of gastro-esophageal reflux disease. United European Gastroenterol J. 2024 Jun;12(5):552-561. doi: 10.1002/ueg2.12565. Epub 2024 Mar 27.

    PMID: 38536701DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Stefano Siboni, MD

    IRCCS Policlinico S. Donato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective descriptive study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 29, 2023

First Posted

May 9, 2023

Study Start

December 1, 2022

Primary Completion

February 28, 2023

Study Completion

April 29, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)