Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03596476
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2018-07-11
Brief Title:
Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMER
Brief 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 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
Hypothesis The 1-hour post prandial esophageal HRIM might be useful to diagnose GERD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-A01591-54 | OTHER | ID-RCB | None |