Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy (PRIMER)

June 25, 2024 updated by: Hospices Civils de Lyon

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Chambray-lès-Tours, France, 37171
        • Recruiting
        • Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours
        • Contact:
          • Alexandre AUBOURG, MD
        • Principal Investigator:
          • Alexandre AUBOURG, MD
      • Colombes, France, 92700
        • Recruiting
        • Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP
        • Contact:
          • Benoit COFFIN, MD
        • Principal Investigator:
          • Benoit COFFIN, MD
      • Lyon, France, 69437
        • Recruiting
        • Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL
        • Contact:
          • Sabine ROMAN, MD
        • Principal Investigator:
          • Sabine ROMAN, MD
      • Nantes, France, 44093
        • Recruiting
        • Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes
        • Contact:
          • Stanislas BRULEY DES VARANNES, MD
        • Principal Investigator:
          • Stanislas BRULEY DES VARANNES, MD
      • Pessac, France, 33600
        • Recruiting
        • Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux
        • Contact:
          • Frank ZERBIB, MD
        • Principal Investigator:
          • Frank Zerbib, MD
      • Rennes, France, 35033
        • Recruiting
        • Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes
        • Contact:
          • Marion CHAMBAZ, MD
        • Principal Investigator:
          • Marion CHAMBAZ, MD
      • Rouen, France, 76031
        • Recruiting
        • Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen
        • Contact:
          • Guillaume GOURCEROL, MD
        • Principal Investigator:
          • Guillaume GOURCEROL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with persistent GERD
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
Procedure: Upper gastrointestinal (GI) endoscopy
An upper gastrointestinal (GI) endoscopy will be performed at V1. Four esophageal biopsies will be taken in both the proximal and the distal esophagus.
Procedure: Wireless pH monitoring
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).
Procedure: Post prandial esophageal High Resolution Impedance Manometry
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.
Procedure: pH-impedance monitoring
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1 hour after the end of the meal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acid exposure time measured on wireless pH-monitoring
Time Frame: 4 days
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.
4 days
Reflux mechanisms defined on post prandial HRIM
Time Frame: 1 hour after the end of the meal
Description of the reflux mechanisms associated with reflux episodes: rumination, transient lower esophageal sphincter relaxation (TLESR), defective esophago-gastric junction (EGJ) or unknown.
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
Measure of baseline impedance on a period without swallow 3 and 5 cm above the proximal border of the esophago-gastric junction
1 hour after the end of the meal
Resting pressure of the esophago-gastric junction
Time Frame: 1 hour
Measure of the resting pressure of the esophago-gastric junction on a period without swallowing
1 hour
Esophageal histology
Time Frame: 4 weeks
Presence of eosinophils cells in the esophageal mucosa > 15/hpf, dilated intercellular spaces, and/or papillar elongation
4 weeks
Response to 4-week regimen of dose PPI
Time Frame: 4 weeks
Clinical response is defined as a Reflux Disease Questionnaire score on PPI ≤ 3 after 4-week treatment
4 weeks
Normalization of the number of reflux episodes detected on 24-h pH-impedance monitoring performed on PPI
Time Frame: 1 day
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.
1 day
Normalization of the acid exposure time measured on 24-h pH-impedance monitoring performed on PPI
Time Frame: 1 day
The esophageal acid exposure (AET) is normalized if it is below 4% on pH-impedance monitoring performed on PPI.
1 day
Patient's preference regarding the type of examination
Time Frame: 1 day
Percentage of patients who preferred the wireless pH capsule and percentage of patients who preferred HRIM.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL18_0043
  • 2018-A01591-54 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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