The aim of this study is to assess the compliance of the EGJ in patients with achalasia and to compare this to LES pressure and the dysphagia score. We hypothesize that compliance measurement of the EGJ by endoflip in achalasia can warrant us extra…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- EGJ compliance
Secondary outcome
- questionnaire scores
- LES resting pressure
Background summary
Achalasia is a rare motility disorder of the esophagus, with an incidence of 1
per 100.000. Although it is a rare disorder, it is commonly seen in specialized
academic centres.
Unexplained damage to the nerve endings in the esophagus leads to loss of
peristalsis and defective relaxation of the lower esophageal sphincter (LES).
The subsequent retention of foods and saliva in the esophagus leads to the
typical symptoms of achalasia: dysphagia, regurgitation of undigested food,
respiratory complications, chest pain and weight loss.
Treatment options for achalasia aim at reducing LES tone, and thereby relieving
of functional obstruction and improving the bolus transport across the LES. The
loss of esophageal peristalsis is irreversible.
The treatment option of preference is pneumodilation. Pneumatic dilation
therapy disrupts the LES by forceful inflation of an air-filled balloon, which
yields good results in up to 80% of patients. However, relapse rates are high,
and as achalasia is a lifelong disorder, patients are treated multiple times
frequently.
EndoFLIP is a diagnostic tool for assessing the competence of the esophageal
gastric junction (EGJ), by challenging its compliance. The prototype of the
Endoflip was used in our lab to assess the compliance of the EGJ before and
after eradacation of Barrett*s epithelium.
Esophageal manometry combined with symptom scores are used to decide whether
new treatment is indicated. Frequently patients have low residual LES pressure
during esophageal manometry, but experience daily dysphagia. Especially after
first dilation there is no good quantification of LES function, as scarring
takes place. Scarring leads to an impaired compliance and thereby dysphagia,
but this cannot be measured by LES pressure.
Study objective
The aim of this study is to assess the compliance of the EGJ in patients with
achalasia and to compare this to LES pressure and the dysphagia score. We
hypothesize that compliance measurement of the EGJ by endoflip in achalasia can
warrant us extra information on the EGJ. Eventually that can guide the decision
on further treatment.
Study design
Prospective validation of a new diagnostic entity.
Study burden and risks
Risk of the procedure is limited. The procedure is unpleasant, but well
tolerated. Eventually the research can lead to a better measurement of LES
function in patients with achalasia.
Meibergdreef 9, postbus 22660
1100 DD Amsterdam
NL
Meibergdreef 9, postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Written informed consent
Age 18-80 years
Achalasia, diagnosed by esophageal manometry
Exclusion criteria
Pseudo achalasia
Inability to undergo manometry
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 | NL30041.018.09 |