Gastro Esophageal RefluxHRM nomogramNCT05851482
Validation of HRM Score for the GERD Diagnosis
A study testing High resolution manometry in people with Gastro Esophageal Reflux, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- High resolution manometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 29 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Body mass index (BMI) >35 Kg/m2
- prior esophageal surgery
- paraesophageal hiatal hernia
- eosinophilic esophagitis
- scleroderma
- esophageal achalasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NOVEL HIGH-RESOLUTION MANOMETRY SCORE FOR THE DIAGNOSIS OF GASTRO-ESOPHAGEAL REFLUX DISEASE
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
Read the 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%).
- Conditions
- Gastro Esophageal Reflux
- Being tested
- High resolution manometry
- Keywords
- High Resolution Manometry, Gastroesophageal reflux disease, Esophagogastric junction, Inta-abdominal pressure, Straight leg raise maneuver
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution manometryDiagnostic test
Standard chicago classification 4.0 HRM protocol
| Study group | Role | What they receive |
|---|---|---|
| GERD | Experimental | Patients with GERD symptoms Receives: Diagnostic Test: High resolution manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRM score
HRM score is based on EJG type, ineffective esophageal motility, straight leg raise maneuver and EGJ contractile integral
Measured: From date of inclusion in the study until the diagnosis of GERD, up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Dec 2022
- Primary completion28 Feb 2023
- Study completion29 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective descriptive study
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Stefano Siboni, IRCCS Policlinico S. Donato
- Investigators
- Stefano Siboni, MD, Principal investigator, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851482
- Sponsor's protocol ID
- HRM Nomogram GERD
- Acronym
- HRM nomogram
- Status last verified
- May 2023
- First submitted
- 29 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 2023 Jul;21(7):1761-1770.e1. doi: 10.1016/j.cgh.2022.10.008. Epub 2022 Oct 19.
PubMed 36270615Siboni 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.
PubMed 38536701
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOVEL HIGH-RESOLUTION MANOMETRY SCORE FOR THE DIAGNOSIS OF GASTRO-ESOPHAGEAL REFLUX DISEASE
- ClinicalTrials.gov ID
- NCT05851482
- Acronym / sponsor ID
- HRM nomogram / HRM Nomogram GERD
- Conditions
- Gastro Esophageal Reflux
- Keywords
- High Resolution Manometry, Gastroesophageal reflux disease, Esophagogastric junction, Inta-abdominal pressure, Straight leg raise maneuver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- 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
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 29 Apr 2023 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective descriptive study
| Arm | Type | Receives |
|---|---|---|
| GERD | Experimental | Diagnostic Test: High resolution manometryPatients with GERD symptoms |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- Body mass index (BMI) >35 Kg/m2
- prior esophageal surgery
- paraesophageal hiatal hernia
- eosinophilic esophagitis
- scleroderma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High resolution manometryStandard chicago classification 4.0 HRM protocol | Diagnostic test | GERD |
Primary outcome
HRM score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 36270615Siboni 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.
- Derived from this study: PubMed 38536701Siboni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Siboni, MD principal investigator
IRCCS Policlinico S. Donato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High resolution manometry in people with Gastro Esophageal Reflux, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRM score (time frame: From date of inclusion in the study until the diagnosis of GERD, up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851482, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.