Acid Pocket: Position and Aspiration

Not Applicable

Completed

• Conditions: Healthy Volunteers; GERD - PPI Responders; Barrett Esophagus; GERD - PPI Non-responders
• Interventions: Device: multi-pH-impedance manometry catheter

• Registration Number: NCT02199002
• Lead Sponsor: KU Leuven

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-24
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
barrett - high grade dysplasia	multi-pH-impedance manometry catheter	proven barrett with high grade dysplasia on biopsies
Barrett - no dysplasia	multi-pH-impedance manometry catheter	proven barrett with no dysplasia on biopsies
healthy volunteers	multi-pH-impedance manometry catheter	healthy volunteers (no gastric complains)
PPI responders	multi-pH-impedance manometry catheter	proven reflux, good symptom relief upon PPI therapy
PPI non-responders	multi-pH-impedance manometry catheter	proven reflux disease, poor symptom control (less then 50% symptom reduction) upon PPI therapy (2x40mg omeprazole)

Primary Outcome Measures

Name	Time	Method
acid pocket position	participants will be followed for 24 hours	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

Secondary Outcome Measures

Name	Time	Method
number of reflux episodes	24 hours	number of reflux episodes will be counted and compared between the different groups.

Trial Locations

Locations (1)

Catholic University Leuven; 🇧🇪 Leuven, Belgium