Post Prandial High Resolution Impedance- Manometry

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.

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Key information

Conditions

Gastro-esophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot, Lyon, France

Lyon, 69437, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

Primary outcomes

High Resolution Impedance Manometry

Time frame: 1 hour

Number of reflux episodes detected on high resolution impedance manometry during the one hour following the meal
24-h pH-impedance

Time frame: 24 hour

Number of reflux episodes detected on 24-h ambulatory esophageal pH-impedance monitoring

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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)

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: Oct 11, 2017
Registry last updated: Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed