Gastro-esophageal RefluxNCT03306485
Post Prandial High Resolution Impedance- Manometry
An observational study of Gastro-esophageal Reflux, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) - suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of patients have persistent symptoms on proton pump inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-esophageal Reflux
- What is being tested?
- Correlating the number of reflux episodes detected on 1-h post prandial esophageal high resolution manometry combined and those detected on ambulatory 24-h pH-impedance monitoring performed on PPI
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2017to 27 Feb 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with Gastro-esophageal reflux disease symptoms refractory to proton pump inhibitor therapy
Who may be able to join
- Patient of both gender older than 18 years
- Patient referred for post prandial esophageal high resolution manometry combined with impedance and ambulatory 24-h pH-impedance monitoring on proton pump inhibitor
- Heartburn and/or regurgitation despite double dose proton pump inhibitor therapy
- Proven Gastro-esophageal reflux disease off proton pump inhibitor (Los Angeles grade B, C or D esophagitis and/or esophageal acid exposure > 5% on esophageal pH monitoring off proton pump inhibitor)
- Absence of major esophageal motility disorders (achalasia, esophago-gastric junction outflow obstruction, esophageal spasm, jackhammer esophagus, absent contractions)
- Patient who does not decline to participate to the study
Who cannot join
- Patient younger than 18 years
- Pregnancy or breast feeding
- Previous history of esophago-gastric surgery ( including anti-reflux surgery, Heller myotomy, bariatric surgery)
- Patient with severe renal insufficiency
- Patient with severe cardiac insufficiency
- Patient legally incompetent or unable to give consent
- Patient who declines to participate to the study
- Participation to another study at the same time
Trial locations and contacts
1 site in 1 country.
France1 site
Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot, Lyon, France
Lyon, 69437
About this study
Official title: Evaluation of Diagnostic Performances of Esophageal Post Prandial High Resolution Impedance- Manometry (HRIM) in Patients With Gastro-esophageal Reflux Disease (GERD) Resistant to Proton Pump Inhibitor (PPI) Treatment : Pilot Study (MHR POST-PRANDIALE)
Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) - suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of patients have persistent symptoms on proton pump inhibitor. Complementary examinations are then required to determine the cause of persistent symptoms (non compliance to treatment, persistent esophageal acid exposure despite proton pump inhibitor, non acid reflux, reflux hypersensitivity, functional symptoms, rumination syndrome…). The gold standard to detect reflux episodes in patients on proton pump inhibitor therapy is 24-h ambulatory esophageal pH-impedance monitoring. Esophageal High Resolution Impedance-Manometry might help to determine gastro-esophageal reflux disease mechanisms especially when performed post prandially. Further some publications demonstrated that the number of reflux episodes detected during the post prandial period might be well correlated to the total number of reflux episodes recorded during 24 h.
The hypothesis of this study is that 1-hour post prandial esophageal High Resolution Impedance-Manometry might be useful to diagnose gastro-esophageal reflux disease and can replace in some instances 24-h esophageal pH-impedance monitoring. Therefore the aim is to compare the number of reflux episodes detected with esophageal High Resolution Impedance-Manometry performed during 1-h post prandial period to the total number of reflux episodes detected during 24-h ambulatory esophageal pH-impedance monitoring.
- Conditions
- Gastro-esophageal Reflux
- Being tested
- Correlating the number of reflux episodes detected on 1-h post prandial esophageal high resolution manometry combined and those detected on ambulatory 24-h pH-impedance monitoring performed on PPI
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correlating the number of reflux episodes detected on 1-h post prandial esophageal high resolution manometry combined and those detected on ambulatory 24-h pH-impedance monitoring performed on PPIOther
Esophageal high resolution impedance manometry (HRIM) consists of introducing a transnasal probe to record esophageal contractility (manometry), bolus transit (impedance) but also the occurrence of reflux episodes. Ambulatory 24-h pH-impedance monitoring consists of recording the occurrence of reflux episodes by introducing a transnasal catheter into the esophagus. After inserting the transnasal HRIM probe and the pH-impedance catheter, both HRIM and 24-h pH-impedance recordings are started. The patient is instructed to eat a meal that induces reflux symptoms (the patient brings his own meal). One hour the end of the meal, the HRIM probe is removed. The patient is discharged at home and the 24-h pH-impedance monitoring is continued. The patient is coming back 24-h after catheter insertion to stop the pH-impedance recording and remove the catheter.
| Study group | Role | What they receive |
|---|---|---|
| Patients with GERD symptoms refractory to PPI therapy | Patients with proven GERD (gastro-esophageal reflux disease) off PPI (proton pump inhibitor) (Los Angeles grade B, C or D esophagitis and/or esophageal acid exposure > 5% on pH monitoring performed off PPI).
These patients have persistent heartburn and/or regurgitation despite double dose proton pump inhibitor. Patients are referred for esophageal high resolution impedance manometry and ambulatory 24-h pH-impedance monitoring on proton pump inhibitor. Receives: Other: Correlating the number of reflux episodes detected on 1-h post prandial esophageal high resolution manometry combined and those detected on ambulatory 24-h pH-impedance monitoring performed on PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Resolution Impedance Manometry
Number of reflux episodes detected on high resolution impedance manometry during the one hour following the meal
Measured: 1 hour
24-h pH-impedance
Number of reflux episodes detected on 24-h ambulatory esophageal pH-impedance monitoring
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start21 Dec 2017
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-esophageal RefluxStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306485
- Sponsor's protocol ID
- 69HCL17_0427
- Status last verified
- Mar 2023
- First submitted
- 5 Oct 2017
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Performances of Esophageal Post Prandial High Resolution Impedance- Manometry (HRIM) in Patients With Gastro-esophageal Reflux Disease (GERD) Resistant to Proton Pump Inhibitor (PPI) Treatment : Pilot Study (MHR POST-PRANDIALE)
- ClinicalTrials.gov ID
- NCT03306485
- Acronym / sponsor ID
- 69HCL17_0427
- Conditions
- Gastro-esophageal Reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 11 Oct 2017 (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.
Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) - suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of patients have persistent symptoms on proton pump inhibitor. Complementary examinations are then required to determine the cause of persistent symptoms (non compliance to treatment, persistent esophageal acid exposure despite proton pump inhibitor, non acid reflux, reflux hypersensitivity, functional symptoms, rumination syndrome…). The gold standard to detect reflux episodes in patients on proton pump inhibitor therapy is 24-h ambulatory esophageal pH-impedance monitoring. Esophageal High Resolution Impedance-Manometry might help to determine gastro-esophageal reflux disease mechanisms especially when performed post prandially. Further some publications demonstrated that the number of reflux episodes detected during the post prandial period might be well correlated to the total number of reflux episodes recorded during 24 h.
The hypothesis of this study is that 1-hour post prandial esophageal High Resolution Impedance-Manometry might be useful to diagnose gastro-esophageal reflux disease and can replace in some instances 24-h esophageal pH-impedance monitoring. Therefore the aim is to compare the number of reflux episodes detected with esophageal High Resolution Impedance-Manometry performed during 1-h post prandial period to the total number of reflux episodes detected during 24-h ambulatory esophageal pH-impedance monitoring.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with GERD symptoms refractory to PPI therapy | – | Other: Correlating the number of reflux episodes detected on 1-h post prandial esophageal high resolution manometry combined and those detected on ambulatory 24-h pH-impedance monitoring performed on PPIPatients with proven GERD (gastro-esophageal reflux disease) off PPI (proton pump inhibitor) (Los Angeles grade B, C or D esophagitis and/or esophageal acid exposure > 5% on pH monitoring performed off PPI). These patients have persistent heartburn and/or regurgitation despite double dose proton pump inhibitor. Patients are referred for esophageal high resolution impedance manometry and ambulatory 24-h pH-impedance monitoring on proton pump inhibitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Gastro-esophageal reflux disease symptoms refractory to proton pump inhibitor therapy
Key inclusion criteria (6 listed)
- Patient of both gender older than 18 years
- Patient referred for post prandial esophageal high resolution manometry combined with impedance and ambulatory 24-h pH-impedance monitoring on proton pump inhibitor
- Heartburn and/or regurgitation despite double dose proton pump inhibitor therapy
- Proven Gastro-esophageal reflux disease off proton pump inhibitor (Los Angeles grade B, C or D esophagitis and/or esophageal acid exposure > 5% on esophageal pH monitoring off proton pump inhibitor)
- Absence of major esophageal motility disorders (achalasia, esophago-gastric junction outflow obstruction, esophageal spasm, jackhammer esophagus, absent contractions)
Key exclusion criteria (8 listed)
- Patient younger than 18 years
- Pregnancy or breast feeding
- Previous history of esophago-gastric surgery ( including anti-reflux surgery, Heller myotomy, bariatric surgery)
- Patient with severe renal insufficiency
- Patient with severe cardiac insufficiency
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 |
|---|---|---|
| Correlating the number of reflux episodes detected on 1-h post prandial esophageal high resolution manometry combined and those detected on ambulatory 24-h pH-impedance monitoring performed on PPIEsophageal high resolution impedance manometry (HRIM) consists of introducing a transnasal probe to record esophageal contractility (manometry), bolus transit (impedance) but also the occurrence of reflux episodes. Ambulatory 24-h pH-impedance monitoring consists of recording the occurrence of reflux episodes by introducing a transnasal catheter into the esophagus. After inserting the transnasal HRIM probe and the pH-impedance catheter, both HRIM and 24-h pH-impedance recordings are started. The patient is instructed to eat a meal that induces reflux symptoms (the patient brings his own meal). One hour the end of the meal, the HRIM probe is removed. The patient is discharged at home and the 24-h pH-impedance monitoring is continued. The patient is coming back 24-h after catheter insertion to stop the pH-impedance recording and remove the catheter. | Other | Patients with GERD symptoms refractory to PPI therapy |
Primary outcome
High Resolution Impedance Manometry
Time frame: 1 hour
Number of reflux episodes detected on high resolution impedance manometry during the one hour following the meal
24-h pH-impedance
Time frame: 24 hour
Number of reflux episodes detected on 24-h ambulatory esophageal pH-impedance monitoring
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 30 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro-esophageal Reflux, run by Hospices Civils de Lyon at 1 site in France.
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 6 inclusion and 8 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 30 Mar 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 France. 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?
High Resolution Impedance Manometry (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2023.