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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours
RECRUITING
Chambray-lès-tours
Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP
RECRUITING
Colombes
Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL
RECRUITING
Lyon
Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes
RECRUITING
Nantes
Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux
RECRUITING
Pessac
Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes
RECRUITING
Rennes
Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen
RECRUITING
Rouen
Contact Information
Primary
Sabine ROMAN, MD
sabine.roman@chu-lyon.fr
4 72 11 01 36
Time Frame
Start Date: 2021-05-03
Estimated Completion Date: 2027-05-03
Participants
Target number of participants: 330
Treatments
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
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov