Acid Pocket: Position and Aspiration

Study Overview
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Brief Summary
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Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this therapy. As the mechanisms underlying symptom perception in PPI resistant patients are not fully understood, there is currently no adequate therapy available. It is becoming increasingly clear that reflux, especially in the postprandial period, occurs from a reservoir of acid floating on top of the meal: the so-called acid pocket. In this study, we aim to investigate further the acid pocket by determining its exact position and chemical contents between healthy volunteers, GERD patient who respond well and bad to PPI therapy and GERD patients with barrett's esophagus.

Detailed Description
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A costume made multi-pH-impedance manometry catheter will be placed in the esophagus and clipped to the Z-line. Patients then will be given a standardized meal and the position of the acid pocket will be measured. After two hours the pocket will be aspirated through a gastric catheter. Then, patients will be allowed to return home and the study will be continued for another 22 hours. The special catheter will be removed at the end of the study. Collected acid pockets will be used to analyze content and perform permeability experiments. Data of the 24-hour experiment will be used to evaluate the position of the acid pocket and number of reflux episodes.

Official Title
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Acid Pocket: Different Position and Chemical Content Between Healthy Volunteers and GERD Patients

Conditions
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GERD - PPI Responders, GERD - PPI Non-responders, Barrett Esophagus, Healthy Volunteers

Intervention / Treatment
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* Device: multi-pH-impedance manometry catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed consent older than 18 years fit to criteria of 'study population' (HV, PPI responder, PPI non-responder, Barrett) Exclusion Criteria: pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: healthy volunteers<br>healthy volunteers (no gastric complains) | Device: multi-pH-impedance manometry catheter<br>* a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.<br>|
| Other: PPI responders<br>proven reflux, good symptom relief upon PPI therapy | Device: multi-pH-impedance manometry catheter<br>* a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.<br>|
| Other: PPI non-responders<br>proven reflux disease, poor symptom control (less then 50% symptom reduction) upon PPI therapy (2x40mg omeprazole) | Device: multi-pH-impedance manometry catheter<br>* a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.<br>|
| Other: Barrett - no dysplasia<br>proven barrett with no dysplasia on biopsies | Device: multi-pH-impedance manometry catheter<br>* a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.<br>|
| Other: barrett - high grade dysplasia<br>proven barrett with high grade dysplasia on biopsies | Device: multi-pH-impedance manometry catheter<br>* a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acid pocket position | Acid position will be determined relatively to the lower esophageal sfincter. Differences in position between healthy volunteers, PPI responders, PPI non-responders and patients with barrett esophagus will be evaluated | participants will be followed for 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of reflux episodes | number of reflux episodes will be counted and compared between the different groups. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acid pocket, GERD, Barrett