Gastro-esophageal Reflux DiseasePRIMERNCT03596476
Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy
A study testing Upper gastrointestinal (GI) endoscopy, Wireless pH monitoring and Post prandial esophageal High Resolution Impedance Manometry in people with Gastro-esophageal Reflux Disease, run by Hospices Civils de Lyon at 7 sites in France.
Trial summary
Gastro-esophageal reflux disease (GERD) is defined as the reflux of gastric content into the esophagus that causes troublesome symptoms or complications. Nine to 30% of the population suffers from GERD-suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-esophageal Reflux Disease
- What is being tested?
- Upper gastrointestinal (GI) endoscopy, Wireless pH monitoring and Post prandial esophageal High Resolution Impedance Manometry
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 7 sitesFrance
- Study dates
- 3 May 2021to 3 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18 years
- Typical symptoms of GERD (heartburn, regurgitation) at least twice a week despite PPI therapy for at least one month.
- Reflux Disease Questionnaire (RDQ) score off PPI > 3
- Subject with health insurance
Who cannot join
- Previous esophago-gastric surgery,
- Previous history of developing esophageal or gastric tumor, esophageal stricture, or esophageal varices
- Pregnancy (assessment at V0)
- Contraindication to general anesthesia,
- Contraindications to the wireless capsule pH-monitoring: pacemakers, implantable cardiac defibrillator,
- Contraindications to HRIM: inability to tolerate nasal intubation, significant bleeding disorders for which nasal intubation is contraindicated, known esophageal obstruction is preventing the passage of the HRIM probe.
Show all 12Show fewer
- Intolerance or allergy to one component of the test meal,
- Intolerance or allergy to PPI,
- Inability to give consent,
- Mentally unbalanced patients, under supervision or guardianship
- Decline to participate in the study,
- Participation in another study at the same time
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours
Chambray-lès-Tours, 37171
Alexandre AUBOURG, MD
Alexandre AUBOURG, MD
- Recruiting
Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP
Colombes, 92700
Benoit COFFIN, MD
Benoit COFFIN, MD
- Recruiting
Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL
Lyon, 69437
Sabine ROMAN, MD
Sabine ROMAN, MD
- Recruiting
Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes
Nantes, 44093
Stanislas BRULEY DES VARANNES, MD
Stanislas BRULEY DES VARANNES, MD
- Recruiting
Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux
Pessac, 33600
Frank ZERBIB, MD
Frank ZERBIB, MD
- Recruiting
Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes
Rennes, 35033
Marion CHAMBAZ, MD
Marion CHAMBAZ, MD
- Recruiting
Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen
Rouen, 76031
Guillaume GOURCEROL, MD
Guillaume GOURCEROL, MD
About this study
Gastro-esophageal reflux disease (GERD) is defined as the reflux of gastric content into the esophagus that causes troublesome symptoms or complications. Nine to 30% of the population suffers from GERD-suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). In the absence of warning signs, proton pump inhibitors (PPI) are prescribed as first-line treatment. However, 20 to 60% of patients are unsatisfied because of persistent symptoms when taking PPI. Causes of persistent symptoms are: erroneous diagnosis of GERD (up to 50% of PPI non-responders), rumination syndrome, excessive weakly acid reflux on PPI due to defective esophago-gastric junction or an excessive number of transient lower esophageal sphincter relaxations (main mechanism of GERD), poor acid secretion inhibition on PPI, and non-compliance to therapy. Complementary examinations are indicated to explain persistent GERD symptoms. Upper gastro-intestinal endoscopy is performed first to rule out an esophageal tumor and to identify erosive esophagitis, a specific sign of GERD. However, it is normal in up to 70% of symptomatic GERD patients. Direct detection of reflux episodes is then requested to confirm GERD. The gold standard for reflux detection is the ambulatory measurement of esophageal pH for 24 to 96 hours using a catheter (catheter-based pH-monitoring) or a capsule clipped into the esophagus (wireless pH-monitoring). Reflux episodes are defined as an esophageal pH < 4. Another method of reflux detection is based on liquid and gas detection in the esophagus using pH-impedance monitoring. Recently the combination of impedance and esophageal pressure monitoring, called esophageal high resolution impedance manometry (HRIM) was introduced to simultaneously identify reflux episodes and their mechanisms. It has several advantages over esophageal pH measurement: shorter recording duration (1 or 2 hours post prandial) and identification of reflux mechanisms that might guide the choice of the best therapeutic option.
Hypothesis: The 1-hour post prandial esophageal HRIM might be useful to diagnose GERD.
- Conditions
- Gastro-esophageal Reflux Disease
- Being tested
- Upper gastrointestinal (GI) endoscopy, Wireless pH monitoring, Post prandial esophageal High Resolution Impedance Manometry, pH-impedance monitoring
- Keywords
- Gastro-esophageal reflux, High resolution Impedance Manometry, Resistance to proton pump inhibitors (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.
Upper gastrointestinal (GI) endoscopyProcedure or surgery
An upper gastrointestinal (GI) endoscopy will be performed at V1. Four esophageal biopsies will be taken in both the proximal and the distal esophagus.
Wireless pH monitoringProcedure or surgery
Wireless pH monitoring will be performed at V1. The pH capsule will be clipped into the esophagus during the upper GI endoscopy. The esophageal pH will be recorded for 96 hours (ambulatory recording).
Post prandial esophageal High Resolution Impedance ManometryProcedure or surgery
Post prandial esophageal HRIM will be performed at V2. The recording will be started after transnasal insertion of the HRIM probe. A standardized meal will be given to the patient (Big Mac, medium portion of French fries, orange juice). The recording will be realized for one hour after the end of the meal.
pH-impedance monitoringProcedure or surgery
24-h pH-impedance monitoring on PPI will be performed at V3. A transnasal catheter will be inserted into the esophagus and the recording will be performed for 24 hours (ambulatory recording).
| Study group | Role | What they receive |
|---|---|---|
| Patients with persistent GERD | Experimental | Patients with persistent GERD suggestive symptoms despite PPI therapy. All the patients will undergo an upper gastrointestinal (GI) endoscopy, a wireless pH monitoring and a post prandial esophageal High Resolution Impedance Manometry (HRIM). Optional: 24-h pH-impedance monitoring on PPI Receives: Procedure: Upper gastrointestinal (GI) endoscopy; Procedure: Wireless pH monitoring; Procedure: Post prandial esophageal High Resolution Impedance Manometry; Procedure: pH-impedance monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of reflux episodes identified on the post prandial HRIM
The diagnostic performance of the number of reflux episodes measured by 1-hour post prandial HRIM will be evaluated by estimating the Area Under the ROC Curve and its 95% confidence interval. The gold standard to define GERD will be based on esophageal pH measurements with capsule (GERD is defined as acid exposure time (AET; percentage of total time with esophageal pH < 4) greater than 6% for at least one day on wireless pH monitoring).
Measured: 1 hour after the end of the meal
Secondary outcomes (9)
Acid exposure time measured on wireless pH-monitoring
The diagnosis of GERD based on pH-monitoring. The diagnosis of GERD is positive if acid exposure time (AET; percentage of total time with esophageal pH < 4) is greater than 6% for at least one day on wireless pH monitoring. The diagnosis of GERD is negative (ie absence of GERD) if the AET is below 4% during the 4 days of wireless monitoring. In the other instance , the diagnosis of GERD is uncertain.
Measured: 4 days
Reflux mechanisms defined on post prandial HRIM
Description of the reflux mechanisms associated with reflux episodes: rumination, transient lower esophageal sphincter relaxation (TLESR), defective esophago-gastric junction (EGJ) or unknown.
Measured: 1 hour after the end of the meal
Baseline impedance measured on post prandial HRIM
Measure of baseline impedance on a period without swallow 3 and 5 cm above the proximal border of the esophago-gastric junction
Measured: 1 hour after the end of the meal
Resting pressure of the esophago-gastric junction
Measure of the resting pressure of the esophago-gastric junction on a period without swallowing
Measured: 1 hour
Esophageal histology
Presence of eosinophils cells in the esophageal mucosa > 15/hpf, dilated intercellular spaces, and/or papillar elongation
Measured: 4 weeks
Response to 4-week regimen of dose PPI
Clinical response is defined as a Reflux Disease Questionnaire score on PPI ≤ 3 after 4-week treatment
Measured: 4 weeks
Normalization of the number of reflux episodes detected on 24-h pH-impedance monitoring performed on PPI
The number of reflux episodes is normalized if the total number of reflux episodes is < 60 /24 h) on pH-impedance monitoring performed on PPI.
Measured: 1 day
Normalization of the acid exposure time measured on 24-h pH-impedance monitoring performed on PPI
The esophageal acid exposure (AET) is normalized if it is below 4% on pH-impedance monitoring performed on PPI.
Measured: 1 day
Patient's preference regarding the type of examination
Percentage of patients who preferred the wireless pH capsule and percentage of patients who preferred HRIM.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start3 May 2021
- Primary completion3 May 2027 (estimated)
- Study completion3 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-esophageal Reflux DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
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
- NCT03596476
- Sponsor's protocol ID
- 69HCL18_0043
- Other IDs
- 2018-A01591-54
- Acronym
- PRIMER
- Status last verified
- Jun 2024
- First submitted
- 11 Jul 2018
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT03596476
- Acronym / sponsor ID
- PRIMER / 69HCL18_0043
- Conditions
- Gastro-esophageal Reflux Disease
- Keywords
- Gastro-esophageal reflux, High resolution Impedance Manometry, Resistance to proton pump inhibitors (PPI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 3 May 2027 (estimated)
- Study completion
- 3 May 2027 (estimated)
- First posted
- 23 Jul 2018 (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.
Gastro-esophageal reflux disease (GERD) is defined as the reflux of gastric content into the esophagus that causes troublesome symptoms or complications. Nine to 30% of the population suffers from GERD-suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). In the absence of warning signs, proton pump inhibitors (PPI) are prescribed as first-line treatment. However, 20 to 60% of patients are unsatisfied because of persistent symptoms when taking PPI. Causes of persistent symptoms are: erroneous diagnosis of GERD (up to 50% of PPI non-responders), rumination syndrome, excessive weakly acid reflux on PPI due to defective esophago-gastric junction or an excessive number of transient lower esophageal sphincter relaxations (main mechanism of GERD), poor acid secretion inhibition on PPI, and non-compliance to therapy. Complementary examinations are indicated to explain persistent GERD symptoms. Upper gastro-intestinal endoscopy is performed first to rule out an esophageal tumor and to identify erosive esophagitis, a specific sign of GERD. However, it is normal in up to 70% of symptomatic GERD patients. Direct detection of reflux episodes is then requested to confirm GERD. The gold standard for reflux detection is the ambulatory measurement of esophageal pH for 24 to 96 hours using a catheter (catheter-based pH-monitoring) or a capsule clipped into the esophagus (wireless pH-monitoring). Reflux episodes are defined as an esophageal pH < 4. Another method of reflux detection is based on liquid and gas detection in the esophagus using pH-impedance monitoring. Recently the combination of impedance and esophageal pressure monitoring, called esophageal high resolution impedance manometry (HRIM) was introduced to simultaneously identify reflux episodes and their mechanisms. It has several advantages over esophageal pH measurement: shorter recording duration (1 or 2 hours post prandial) and identification of reflux mechanisms that might guide the choice of the best therapeutic option.
Hypothesis: The 1-hour post prandial esophageal HRIM might be useful to diagnose GERD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with persistent GERD | Experimental | Procedure: Upper gastrointestinal (GI) endoscopy, Procedure: Wireless pH monitoring, Procedure: Post prandial esophageal High Resolution Impedance Manometry, Procedure: pH-impedance monitoringPatients with persistent GERD suggestive symptoms despite PPI therapy. All the patients will undergo an upper gastrointestinal (GI) endoscopy, a wireless pH monitoring and a post prandial esophageal High Resolution Impedance Manometry (HRIM). Optional: 24-h pH-impedance monitoring on PPI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient older than 18 years
- Typical symptoms of GERD (heartburn, regurgitation) at least twice a week despite PPI therapy for at least one month.
- Reflux Disease Questionnaire (RDQ) score off PPI > 3
- Subject with health insurance
Key exclusion criteria (12 listed)
- Previous esophago-gastric surgery,
- Previous history of developing esophageal or gastric tumor, esophageal stricture, or esophageal varices
- Pregnancy (assessment at V0)
- Contraindication to general anesthesia,
- Contraindications to the wireless capsule pH-monitoring: pacemakers, implantable cardiac defibrillator,
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 |
|---|---|---|
| Upper gastrointestinal (GI) endoscopyAn upper gastrointestinal (GI) endoscopy will be performed at V1. Four esophageal biopsies will be taken in both the proximal and the distal esophagus. | Procedure or surgery | Patients with persistent GERD |
| Wireless pH monitoringWireless pH monitoring will be performed at V1. The pH capsule will be clipped into the esophagus during the upper GI endoscopy. The esophageal pH will be recorded for 96 hours (ambulatory recording). | Procedure or surgery | Patients with persistent GERD |
| Post prandial esophageal High Resolution Impedance ManometryPost prandial esophageal HRIM will be performed at V2. The recording will be started after transnasal insertion of the HRIM probe. A standardized meal will be given to the patient (Big Mac, medium portion of French fries, orange juice). The recording will be realized for one hour after the end of the meal. | Procedure or surgery | Patients with persistent GERD |
| pH-impedance monitoring24-h pH-impedance monitoring on PPI will be performed at V3. A transnasal catheter will be inserted into the esophagus and the recording will be performed for 24 hours (ambulatory recording). | Procedure or surgery | Patients with persistent GERD |
Primary outcome
Number of reflux episodes identified on the post prandial HRIM
Time frame: 1 hour after the end of the meal
The diagnostic performance of the number of reflux episodes measured by 1-hour post prandial HRIM will be evaluated by estimating the Area Under the ROC Curve and its 95% confidence interval. The gold standard to define GERD will be based on esophageal pH measurements with capsule (GERD is defined as acid exposure time (AET; percentage of total time with esophageal pH < 4) greater than 6% for at least one day on wireless pH monitoring).
9 secondary outcomes
Acid exposure time measured on wireless pH-monitoring
Time frame: 4 days
Reflux mechanisms defined on post prandial HRIM
Time frame: 1 hour after the end of the meal
Baseline impedance measured on post prandial HRIM
Time frame: 1 hour after the end of the meal
Resting pressure of the esophago-gastric junction
Time frame: 1 hour
Esophageal histology
Time frame: 4 weeks
Response to 4-week regimen of dose PPI
Time frame: 4 weeks
Normalization of the number of reflux episodes detected on 24-h pH-impedance monitoring performed on PPI
Time frame: 1 day
Normalization of the acid exposure time measured on 24-h pH-impedance monitoring performed on PPI
Time frame: 1 day
Patient's preference regarding the type of examination
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper gastrointestinal (GI) endoscopy, Wireless pH monitoring and Post prandial esophageal High Resolution Impedance Manometry in people with Gastro-esophageal Reflux Disease, run by Hospices Civils de Lyon at 7 sites 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine ROMAN, MD (4 72 11 01 36 ext. +33, sabine.roman@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of reflux episodes identified on the post prandial HRIM (time frame: 1 hour after the end of the meal). 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 26 Jun 2024.