The main objective of this study is to examine the reproducibility of provocative tests and single wet swallows by high-resolution manometry in patients with dysphagia and/or reflux complaints
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the reproducibility of provocative tests during
high-resolution manometry. The reproducibility is determined by concordance of
normal and abnormal outcomes of each provocative test.
Secondary outcome
• Reproducibility of single wet swallows determined by concordance of normal
and abnormal outcomes.
• Agreement of outcome variables between first and second measurement within
one test determined by intraclass correlation coefficient (ICC)
• Change in diagnosis of esophageal motility disorder after second measurement
• Agreement of different outcome variables between single wet swallows and
provocative tests.
Background summary
Dysphagia is the main complaint of patients with an esophageal motility
disorder and this complaint can have a considerable impact on health and
quality of life. The Chicago Classification, which is updated in 2021 to
version 4.0, is a classification of esophageal motility disorders which can be
used to make a diagnose after performing high-resolution manometry. Standard
manometry shows the peristaltic contraction and the function of the lower
esophageal sphincter after ten single wet swallows. According to the Chicago
classification version 4.0, the standard single wet swallows are followed by
provocative tests (e.g. multiple rapid swallows or solid test swallows). It is
presumed that provocative tests can be helpful in clinical management and that
abnormal results of provocative tests in case of normal standard manometry can
clarify patients* complaints. However, results of standard manometry are not
fully compatible with results of provocative tests and it is not clear which
results are the best reflection of the esophageal condition
Study objective
The main objective of this study is to examine the reproducibility of
provocative tests and single wet swallows by high-resolution manometry in
patients with dysphagia and/or reflux complaints
Study design
A single center, prospective, single-arm, non-blinded study.
Study burden and risks
The burden for the subjects is the completion of the dysphagia questionnaires
and two visits for high-resolution manometry of which one visit is already
scheduled because of clinical diagnostic work-up for the dysphagia complaints.
The risks related to the high-resolution manometry are very limited as this
measurement is routinely performed at the Gastroenterology and Hepatology
Department of the Amsterdam UMC. After the measurement, subjects can experience
irritations of the nose or throat because of the placement of the manometry
catheter. This feeling will be temporary and will soon disappear. The findings
of this study could be helpful to accurately diagnose esophageal motility
disorders in future patients with complaints of dysphagia and could be helpful
to choose the optimal treatment.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
• Complaints of dysphagia and/or reflux;
• Age of 18 years or older;
• High-resolution manometry as part of routine clinical practice;
• Written informed consent;
Exclusion criteria
• (Suspect) esophageal motility disorder for which treatment is scheduled
between the two manometry measurements;
• Use of medication which affect gastrointestinal motility that cannot be
stopped (e.g. prokinetics or opioids);
• Another explanation for their dysphagia complaint on previous upper endoscopy
(within three years);
• Previous gastroesophageal surgery (e.g. bariatrics or fundoplication);
• Coeliac disease;
• Insufficient Dutch or English language skills to understand information about
the measurement.
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 | NL83507.018.23 |