Objective: To compare the yield of Symptom Association Probability with two approaches to investigate patients with PPI-resistant symptoms: 24-hour pH monitoring off PPI and 24-hour impedance monitoring on PPI.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: For each reflux measurement the Symptom
Association Probability is calculated. Both methods will be compared according
to Bland-Altman analysis.
Secondary outcome
None
Background summary
Introduction: Excessive gastro-oesophageal reflux can lead to
gastro-oesophageal reflux disease (GORD) with typical reflux symptoms such as
heartburn, regurgitation and chest pain. A therapy with proton pump inhibitors
will normally reduce these symptoms satisfactorily. In some patients however,
symptoms are not reduced satisfactorily by PPIs.
Until recently, patients had to stop their treatment with PPI and had to
perform a 24hr pH monitoring in order to observe if symptoms are related to
acid reflux episodes. With impedance monitoring it is possible to detect reflux
independent of the pH of the refluxate. Therefore it is possible to continue
PPI therapy while performing a combined 24h pH-impedance monitoring in order to
assess the association between symptoms and reflux.
Study objective
Objective: To compare the yield of Symptom Association Probability with two
approaches to investigate patients with PPI-resistant symptoms: 24-hour pH
monitoring off PPI and 24-hour impedance monitoring on PPI.
Study design
Study design: All patients will undergo ambulatory reflux measurement twice.
First, routine manometry is used to measure the distance between the nostrils
and the upper border of the lower oesophageal sphincter. 24-h pH-metry is
performed after cessation of PPIs 7 days in advance. Combined impedance-pH
monitoring is performed while treatment with PPIs is continued. Patients will
use a diary to note onset and type of symptom. Patients are randomised to
either first measurement with or without PPIs.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Participating patients will have to undergo 24h
reflux monitoring twice. In daily practice, only one 24h reflux monitoring is
performed. The 24h pH-impedance monitoring on PPIs is additional, but can
reveal additional information that can be of benefit to the patient. This
information will be communicated towards the patient*s gastroenterologist.
Koekoekslaan 1
3430 EM Nieuwegein
Nederland
Koekoekslaan 1
3430 EM Nieuwegein
Nederland
Listed location countries
Age
Inclusion criteria
age > 18 years
typical reflux symptoms (haertburn, regurgitation, chest pain) that do not repond satisfactorily to double dose PPI-therapy
Exclusion criteria
surgery of stomach or oesophagus in patients history
condition which contraindicates the cessation of PPI therapy such as peptic ulcer disease
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 | NL13921.100.06 |