Gastro-esophageal Reflux Disease (GERD)
Conditions
Brief summary
Does baseline impedance measured during the landmark phase of esophageal High resolution impedance manometry HRIM correlates with direct mucosal impedance measurement and discriminates GERD from non GERD patients?
Detailed description
Patients referred to the Mayo Clinic Rochester for a clinically indicated high resolution impedance manometry (HRIM), 24 hour impedance pH (MII-pH) study, and esophagogastroduodenoscopy (EGD) will be recruited. Gastroesophageal reflux will be defined as a total 24 hour esophageal acid exposure time ≥5% regardless of concomitant Proton Pump inhibitor (PPI) use. A negative 24 hour MII-pH study will be defined as an acid exposure time ≤2% off PPI therapy or ≤1% if on PPI therapy.
Interventions
DEVICEMucosal Impedance
During the clinical endoscopy, the 2.13 mm catheter will be passed through the channel of the standard endoscope this is called an Intraluminal Impedance. The Intraluminal impedance (made by Sandhill Scientific) has not been approved by the Food and Drug Administration (FDA) but it is considered to be minimal risk related to using it. The catheter gives the investigators a reading at each level. * The catheter will be placed on the esophageal mucosa 5 cm above the gastroesophageal junction (where the stomach and esophagus meet) for 5 second * At 10 cm above the gastroesophageal junction the catheter will be placed for 5 seconds * And at 20 cm
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Patients being seen at Mayo clinic Rochester having a clinically indicated endoscopy, a high resolution impedance manometry and a 24 hour pH impedance study. Inclusion criteria: * Adults ages 18-90 * Patients scheduled for or have completed a HRIM ( within 5 days) * Patients scheduled for or recently have completed a MII-pH studies ( within 5 days) * Patients scheduled for EGD
Exclusion criteria
* Technically limited esophageal HRIM or MII-pH study * Patients with HRIM and MII-pH studies not performed within 5 days of each other * Patients with EGD not performed within 30 days of HRIM and MII-pH studies * Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy * Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean impedance | 2 years | The mean impedance measured in Ohms as a measure of mucosal integrity and surrogate for GERD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal impedance measured on HRIM in GERD patients compared to minimal impedance in patients without GERD to determine a potential diagnostic cutoff value | 2 years | Evaluate the measurement of HRIM and mucosal impedance in patients that did not show gastroesophageal reflux disease per the HRIM and impedance testing |
Countries
United States
Outcome results
None listed