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
2 other identifiers
interventional
330
1 country
7
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2018
CompletedFirst Posted
Study publicly available on registry
July 23, 2018
CompletedStudy Start
First participant enrolled
May 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 3, 2027
June 26, 2024
June 1, 2024
6 years
July 11, 2018
June 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
1 hour after the end of the meal
Secondary Outcomes (9)
Acid exposure time measured on wireless pH-monitoring
4 days
Reflux mechanisms defined on post prandial HRIM
1 hour after the end of the meal
Baseline impedance measured on post prandial HRIM
1 hour after the end of the meal
Resting pressure of the esophago-gastric junction
1 hour
Esophageal histology
4 weeks
- +4 more secondary outcomes
Study Arms (1)
Patients with persistent GERD
EXPERIMENTALPatients 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
Interventions
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 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 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.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours
Chambray-lès-Tours, 37171, France
Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP
Colombes, 92700, France
Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL
Lyon, 69437, France
Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes
Nantes, 44093, France
Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux
Pessac, 33600, France
Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes
Rennes, 35033, France
Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen
Rouen, 76031, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2018
First Posted
July 23, 2018
Study Start
May 3, 2021
Primary Completion (Estimated)
May 3, 2027
Study Completion (Estimated)
May 3, 2027
Last Updated
June 26, 2024
Record last verified: 2024-06