Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patien
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 sign
| Condition(s) | Gastro-esophageal Reflux Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 secr |
| Who can participate | 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 passag |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Hospices Civils de Lyon |
| Locations | Chambray-lès-Tours, France; Colombes, France; Lyon, France; Nantes, France; Pessac, France; Rennes, France (+1 more sites) |
| Start date | 2021-05-03 |
| NCT ID | NCT03596476 |
| Official listing | https://clinicaltrials.gov/study/NCT03596476 |