to study the relation between esophageal circular contractions and chest pain episode(s) in treated patients with achalasia by using 24-hour esophageal manometry combined with pH-metry/impedance
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
During each chest pain event, manometric contraction types will be described.
pH-metry and impedance will be used to describe acid reflux events respectively
stasis of fluids in the esophagus during chest pain events.
Secondary outcome
none
Background summary
The mechanism underlying chest pain episodes in patients with achalasia is
poorly understood and has negative impact on quality of life. Spasms of the
esophageal muscle are suspected as a mechanism and for this reason the current
treatment consists of a long acting calcium channel blocker (Adalat OROS).
However, for both pathophysiological mechanism and treatment circumstantial
evidence is lacking. Although high amplitude esophageal contractions have been
demonstrated in patients with achalasia using prolonged manometry, there is no
evidence that these contractions are related to chest pain episodes. Further
more it is unclear if other phenomena, like acid reflux and stasis of fluids in
the distal esophagus contribute to chest pain events.
Study objective
to study the relation between esophageal circular contractions and chest pain
episode(s) in treated patients with achalasia by using 24-hour esophageal
manometry combined with pH-metry/impedance
Study design
Patients will be observed during a period of 2 weeks. During this period each
patient will keep a diary to assess the daytime and night time frequency,
duration and severity of chest pain. If chest pain occurs <5 times/week,
patients will be excluded. This reduces the risk that a chest pain episode is
not present during the actual experiment. The manometric and impedance/pH
catheters will be introduced transnasaly. The distal sensor of the manometry
catheter will be positioned 5 cm proximal to the proximal border of the LES.
The most distal recording segment of the impedance catheter will be positioned
at the level of the upper border of LES. The sensor of the pH catheter will be
positioned 5 cm proximal to the upper border of the LES. Eating and drinking
periods and the incidence of complaints of chest pain, dysphagia and heartburn
will be both marked on the data logger and noted in a diary.
Study burden and risks
-Filling out a diary with regard to symptoms.
-Two extra visits to the hospital: introduction and removal of the manometry
assembly.
-Introduction of the catheter will cause an unpleasant or itchy sensation in
the nose or throat.
Heidelberglaan 100
3584 CX
Nederland
Heidelberglaan 100
3584 CX
Nederland
Listed location countries
Age
Inclusion criteria
achalasia patients with chest pain episodes at least 5 times a week
Exclusion criteria
Lower esophageal sphincter pressure > 10 mmHg
clinical heart disease
requirements of (anti)cholinergic drugs or beta-adrenergic blocking agents
alcohol and/or drug abuse
pregnancy
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 | NL12446.041.06 |