Clinical trial NCT03596476: Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastro-esophageal Reflux Disease
Keywords: Gastro-esophageal reflux
High resolution Impedance Manometry
Resistance to proton pump inhibitors (PPI)
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of reflux episodes identified on the post prandial HRIM
timeFrame: 1 hour after the end of the meal
Secondary outcomes:
measure: Acid exposure time measured on wireless pH-monitoring
timeFrame: 4 days
measure: Reflux mechanisms defined on post prandial HRIM
timeFrame: 1 hour after the end of the meal
measure: Baseline impedance measured on post prandial HRIM
timeFrame: 1 hour after the end of the meal
measure: Resting pressure of the esophago-gastric junction
timeFrame: 1 hour
measure: Esophageal histology
timeFrame: 4 weeks
measure: Response to 4-week regimen of dose PPI
timeFrame: 4 weeks
measure: Normalization of the number of reflux episodes detected on 24-h pH-impedance monitoring performed on PPI
timeFrame: 1 day
measure: Normalization of the acid exposure time measured on 24-h pH-impedance monitoring performed on PPI
timeFrame: 1 day
measure: Patient's preference regarding the type of examination
timeFrame: 1 day
Other outcomes:
Locations:
city: Chambray-lès-Tours
country: France
facility: Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours
city: Colombes
country: France
facility: Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP
city: Lyon
country: France
facility: Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL
city: Nantes
country: France
facility: Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes
city: Pessac
country: France
facility: Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux
city: Rennes
country: France
facility: Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes
city: Rouen
country: France
facility: Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen
Study officials:
References: