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)
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About
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.
Enrollment
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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
Trial design
Primary purpose
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Interventional model
Masking
330 participants in 1 patient group
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Central trial contact
Sabine ROMAN, MD
Data sourced from clinicaltrials.gov
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