The main objective of this study is to investigate whether HRM is able to predict bolus transport of solids and liquids in the oesophagus as adequately as the gold standard, i.e. videofluoroscopy.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameters studied are the intra-bolus pressure, peristaltic amplitude
and sphincter pressure. Prior to the study, patients* symptoms will be assessed
using questionnaires. Furthermore, after each swallow the subjects will have to
indicate whether they believe whether or not complete bolus transport has
occurred.
Secondary outcome
-
Background summary
Since its introduction in the 1950s oesophageal manometry has been the mainstay
in the evaluation of oesophageal motility disorders. With conventional
manometry pressures are usually measured at 5 cm intervals in the oesophagus
and its sphincters. High-Resolution manometry (HRM) is a relatively new tool in
the evaluation of oesophageal motility and can be regarded as a technical
improvement over conventional manometry. Compared to conventional manometry,
the catheter itself contains more sensors and offers the possibility of
studying peristalsis at 1-cm intervals in the entire oesophagus. In addition,
pseudo 3D topographic plots or colour plots can be made, and this facilitates
the interpretation of the results. In analysing patients with oesophageal
motility disorders, is has been suggested that HRM improves understanding of
the precise pathophysiologic mechanism. In particular, in patients with
symptoms of dysphagia in which endoscopy and conventional manometry has
provided no explanation, HRM might be useful as it can hopefully provide a
better explanation for the symptoms, for example by revealing a localized
motility defect causing stasis of the swallowed bolus.
Until now, the gold standard for measurement of bolus transit in the oesophagus
has been videofluoroscopy. However, this technique exposes subjects to ionizing
radiation and is not widely available. It is therefore relevant to investigate
whether HRM can also predict bolus transport in the oesophagus to the same
extent as fluoroscopy does.
Study objective
The main objective of this study is to investigate whether HRM is able to
predict bolus transport of solids and liquids in the oesophagus as adequately
as the gold standard, i.e. videofluoroscopy.
Study design
observational study
Study burden and risks
Participants will simultaneously undergo stationary high-resolution manometry
(HRM) and videofluoroscopy with barium swallows. In addition, they will be
requested to fill in a questionnaire in which the symptoms of dysphagia are
assessed. HRM and fluoroscopy are routine investigations at our department.
No specific risk is associated with these investigations.
Heidelberglaan 100
3508 GA Utrecht
Nederland
Heidelberglaan 100
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
dysphagia, negative upper endoscopy, above 18 years, written informed consent
Exclusion criteria
surgery of the gastrointestinal tract, absence of informed consent, abnormalities on upper endoscopy
Design
Recruitment
Medical products/devices used
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 | NL24288.041.08 |