Acid Pocket: Position and Aspiration

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Barrett Esophagus; GERD - PPI Responders; GERD - PPI Non-responders
• Intervention / Treatment: Device: multi-pH-impedance manometry catheter

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Catholic University Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
acid pocket contents	after collection of all acid pocket, pockets will be processed to determine it's exact chemical content.	1 year

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Guy Boeckxstaens, MD, PhD, Catholic University Leuven

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (ESTIMATE): July 24, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: GERD; acid pocket; Barrett
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: S55731