Clinical trial NCT03306485: Post Prandial High Resolution Impedance- Manometry
Official title: Evaluation of Diagnostic Performances of Esophageal Post Prandial High Resolution Impedance- Manometry (HRIM) in Patients With Gastro-esophageal Reflux Disease (GERD) Resistant to Proton Pump Inhibitor (PPI) Treatment : Pilot Study (MHR POST-PRANDIALE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastro-esophageal Reflux
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Gastro-esophageal reflux disease symptoms refractory to proton pump inhibitor therapy

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patient of both gender older than 18 years
* Patient referred for post prandial esophageal high resolution manometry combined with impedance and ambulatory 24-h pH-impedance monitoring on proton pump inhibitor
* Heartburn and/or regurgitation despite double dose proton pump inhibitor therapy
* Proven Gastro-esophageal reflux disease off proton pump inhibitor (Los Angeles grade B, C or D esophagitis and/or esophageal acid exposure \> 5% on esophageal pH monitoring off proton pump inhibitor)
* Absence of major esophageal motility disorders (achalasia, esophago-gastric junction outflow obstruction, esophageal spasm, jackhammer esophagus, absent contractions)
* Patient who does not decline to participate to the study

Exclusion Criteria:

* Patient younger than 18 years
* Pregnancy or breast feeding
* Previous history of esophago-gastric surgery ( including anti-reflux surgery, Heller myotomy, bariatric surgery)
* Patient with severe renal insufficiency
* Patient with severe cardiac insufficiency
* Patient legally incompetent or unable to give consent
* Patient who declines to participate to the study
* Participation to another study at the same time

Primary outcomes:
measure: High Resolution Impedance Manometry
timeFrame: 1 hour
measure: 24-h pH-impedance
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot, Lyon, France
Study officials:
References: