An observational study in Gastro-esophageal Reflux, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Hospices Civils de Lyon · Observational
Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) - suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of patients have persistent symptoms on proton pump inhibitor. Complementary examinations are then required to determine the cause of persistent symptoms (non compliance to treatment, persistent esophageal acid exposure despite proton pump inhibitor, non acid reflux, reflux hypersensitivity, functional symptoms, rumination syndrome…). The gold standard to detect reflux episodes in patients on proton pump inhibitor therapy is 24-h ambulatory esophageal pH-impedance monitoring. Esophageal High Resolution Impedance-Manometry might help to determine gastro-esophageal reflux disease mechanisms especially when performed post prandially. Further some publications demonstrated that the number of reflux episodes detected during the post prandial period might be well correlated to the total number of reflux episodes recorded during 24 h.
The hypothesis of this study is that 1-hour post prandial esophageal High Resolution Impedance-Manometry might be useful to diagnose gastro-esophageal reflux disease and can replace in some instances 24-h esophageal pH-impedance monitoring. Therefore the aim is to compare the number of reflux episodes detected with esophageal High Resolution Impedance-Manometry performed during 1-h post prandial period to the total number of reflux episodes detected during 24-h ambulatory esophageal pH-impedance monitoring.
1,086 studies on the registry are indexed under Gastroesophageal Reflux; 187 are open to participants now.
This study's enrollment of 9 is below the median of 175 across 304 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Hospices Civils de Lyon is the lead sponsor of 1,854 studies on the registry; 441 are open to participants now.
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Patients with Gastro-esophageal reflux disease symptoms refractory to proton pump inhibitor therapy
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Exclusion Criteria:
Patients with proven GERD (gastro-esophageal reflux disease) off PPI (proton pump inhibitor) (Los Angeles grade B, C or D esophagitis and/or esophageal acid exposure \> 5% on pH monitoring performed off PPI). These patients have persistent heartburn and/or regurgitation despite double dose proton pump inhibitor. Patients are referred for esophageal high resolution impedance manometry and ambulatory 24-h pH-impedance monitoring on proton pump inhibitor.
Other: Correlating the number of reflux episodes detected on 1-h post prandial esophageal high resolution manometry combined and those detected on ambulatory 24-h pH-impedance monitoring performed on PPI
Esophageal high resolution impedance manometry (HRIM) consists of introducing a transnasal probe to record esophageal contractility (manometry), bolus transit (impedance) but also the occurrence of reflux episodes. Ambulatory 24-h pH-impedance monitoring consists of recording the occurrence of reflux episodes by introducing a transnasal catheter into the esophagus. After inserting the transnasal HRIM probe and the pH-impedance catheter, both HRIM and 24-h pH-impedance recordings are started. The patient is instructed to eat a meal that induces reflux symptoms (the patient brings his own meal). One hour the end of the meal, the HRIM probe is removed. The patient is discharged at home and the 24-h pH-impedance monitoring is continued. The patient is coming back 24-h after catheter insertion to stop the pH-impedance recording and remove the catheter.
High Resolution Impedance Manometry
Number of reflux episodes detected on high resolution impedance manometry during the one hour following the meal
Time frame: 1 hour
24-h pH-impedance
Number of reflux episodes detected on 24-h ambulatory esophageal pH-impedance monitoring
Time frame: 24 hour
Plan to share: No
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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