The primary objective of this study is to to relate bio-impedance findings with microscopically measured intercellular spaces inoesophageal epithelium.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To correlate tissue impedance, expressed in Ohm, and degree of dilation of
intercellular spaces with electron microscopy.
Secondary outcome
Not applicable.
Background summary
In the past few decades, understanding has grown substantially about
gastroesophageal reflux disease (GERD). The disease is
caused by reflux of noxious gastric content upwards into the oesophagus. The
disease is common and affects an estimated
20% of the population. Complaints consist of heartburn, regurgitation, and
chest pain. Amongst the normal work-up in these
patients an endoscopy is performed. According to the macroscopic findings
during this procedure, patients can be divided into
two distinct categories. The first group has macroscopic abnormalities of the
oesophagus, presumably caused by the refluxate,
and is categorized as having erosive reflux disease (30-40%, ERD). The second
group shows no abnormalities and is classified
as non-erosive reflux disease (60-70%, NERD).
Although medical treatment with proton pump inhibitors (PPI*s) offer excellent
results and will provide healing of erosions in 85-
95%, a large proportion of patients (up to 40%) do not obtain symptom relief.
Renewed endoscopy in these patients is not
useful as this will not discriminate between either NERD and ERD with healed
erosions, or between NERD and non-GERD
related problems (such as functional causes). In order to be able to
differentiate between these groups without the need for
routine histological examination, a new tool has been developed. Tissue
impedance measurement (TIM) is able, in theory at
least, to determine microscopic damage to the mucosa by way of detecting an
increase in intercellular spaces. The present pilot
study aims to evaluate the feasibility of applying TIM in a clinical
examination and to relate bio-impedance findings with
microscopically measured intercellular spaces in oesophageal epithelium in
normal subjects.
Study objective
The primary objective of this study is to to relate bio-impedance findings with
microscopically measured intercellular spaces in
oesophageal epithelium.
Study design
Observational study.
Study burden and risks
Participants will undergo several routine investigations, such as ECG, blood
tests and an endoscopy. During the endoscopy, a probe will be placed adjacent
to the mucosa of the oesophagus and biopsies will be taken. No specific risk is
associated with
these investigations. However, introduction of the scope van cause irritation
of the throat and sometimes results in vomiting. In general, as soon as the
scope is in place, little inconvenience is noted. Generally, a gastroscopy is
seen as a burdon. After gastroscopy, a sore throat may be noted. This soon
disappears. In addition, biopsies are taken of the oesophagus. This is
associated with the risk of continuous bleeding afterwards. In such a specific
case, additional treatment would be carried out. The injection of midazolam is
associated with a deminished breathing volume and breathing velocity as well as
changes in blood pressure and heart rate. Also, haedaches can occur. Rarely,
pain at the site of injection of hypersensitivity reactions occur.
Heidelberglaan 100
3508 GA Utrecht
NL
Heidelberglaan 100
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
* Females and males between 18 and 45 yrs of age
* No significant clinical pathology or history of heartburn, regurgitation, dysphagia or chest pain or acid
suppressive therapy or any other major abdominal complaints in the last year. No history of signs of pathological
changes of the oesophageal mucosa visible with conventional endoscopic examination
* BMI < 30 or a body weight < 100 kg
* No clinically significant illness within the 2 weeks prior to inclusion or a suspected/manifest infection according
to WHO risk categories 2, 3 or 4, as judged by the investigator
* No history of clinically significant illness, cardiovascular, respiratory, renal, hepatic, neurological, mental or
gastrointestinal, as judged by the investigator
* Normal ECG as judged by the investigator
* Absence of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensivity
* No history of excessive bleeding or suspected coagulopathy
* No prior surgery of the upper GI tract except over sewing of an ulcer
* No use of PPI, H2 receptor antagonists, pro-kinetic drugs or need for any medication for gastroesophageal
reflux disease
* No history of drug addiction (including cannabinoids), alcohol abuse or other circumstances which in the investigator*s judgment may compromise the subject*s participation
* No involvement in the planning and conduct of the study
* No pregnancy or lactation
* Signed informed consent to participate in the study
Exclusion criteria
* Clinically significant illness within the 2 weeks prior to inclusion or a suspected/manifest infection according to
WHO risk categories 2, 3 or 4, as judged by the investigator
* Absence of informed consent
* BMI *30 or a body weight * 100 kg
* History of clinically significant illness, cardiovascular, respiratory, renal, hepatic, neurological, mental or
gastrointestinal, as judged by the investigator
* Abnormal ECG as judged by the investigator
* History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensivity
* History of excessive bleeding or suspected coagulopathy
* Prior surgery of the upper GI tract except over sewing of an ulcer
* Use of PPI, H2 receptor antagonists, pro-kinetic drugs or need for any medication for gastroesophageal reflux
disease
* History of drug addiction (including cannabinoids), alcohol abuse or other circumstances which in the
investigator*s judgment may compromise the subject*s participation
* Inability to comply with study procedures
* Involvement in the planning and conduct of the study
* Previous enrolment in the present study.
* Pregnancy or lactation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32608.041.10 |