To investigate the underlying mechanisms of gastroesophageal reflux and gastroesophageal reflux symptoms in treated achalasia patients.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gastroesophageal reflux episodes.
Secondary outcome
LES pressure.
Esophagogastric junction distensibility.
Sensitivity to acid perfusion and distension.
Level of esophageal stasis.
Widt/diameter of the esophagus.
Background summary
Achalasia is a rare motility disorder of the esophagus that is characterised by
aperistalsis of the esophageal body and dysrelaxation of the lower esophageal
sphincter (LES). Current treatment is palliative and the aim of the treatment
is to diminish the obstructive function of the esophagogastric junction (EGJ).
Due to this approach the most frequent complication post-treatment is
gastroesophageal reflux (GER). However, not every treated patient develops GER
symptoms and the mechanism behind the occurence of GER in treated achalasia are
unclear.
Study objective
To investigate the underlying mechanisms of gastroesophageal reflux and
gastroesophageal reflux symptoms in treated achalasia patients.
Study design
A prospective observational study.
Study burden and risks
Five different measurements will be performed in two subsequent days. Study
subjects will undergo an EndoFLIP, an acid perfusion test, combined
high-resolution manometry (HRM) and pH-impedance monitoring and finally a timed
barium esophagography will be performed. At the beginning of the study
participants will be asked to fill in questionnaires. The measurements are
standard procedures that are routinely performed at the Motility Centre of the
Gastoenterology Department in the evaluation of achalasia patients. The
associated complications are minimal and mainly caused by the placement of the
catheters. The catheters can give discomfort in the nose and pharynx.
Furthermore in rare cases a mucosal bleeding of the nose, caused by the
catheter, can occur which never need extra treatment.
Study subjects will receive 150 euro for study participation, to cover work day
loss. The risks of the measurements are minimal for the study subject. The
results of the study have no consequences for the participants and do not
influence the treatment or the prognosis of the disease. The study will give
insight in the mechanisms behind GER-related symptoms in treated achalasia
which is important for the management of these symptoms and potentially have
consequences for the choice of the initial treatment for achalasia in newly
diagnosed patients. Because the risks for the study subjects in this study are
minimal and the results of the study can give valuable new information it is
justified to perform this study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Treated achalasia patients WITH gastroesophageal reflux symptoms
1) Diagnosis of idiopathic achalasia confirmed by esophageal manometry that shows the following criteria:
- Aperistalsis or simultaneous contractions in the esophageal body.
- LES dysrelaxation.
2) Treatment of achalasia with one of the following procedures:
- Endoscopic balloon dilatation
- Surgical Heller myotomy
- Per-oral endoscopic myotomy (POEM)
3) Minimum total score on the GastroEsophageal Reflux Disease Questionnaire (GERDQ) of * 8.
4) Gastroesophageal symptoms after treatment lasting more than 3 months.
5) Age 18-80 years.
6) Written informed consent.;Treated achalasia patients WITHOUT gastroesophageal reflux symptoms
1) Diagnosis of idiopathic achalasia confirmed by esophageal manometry that shows the following criteria:
- Aperistalsis or simultaneous contractions in the esophageal body.
- LES dysrelaxation.
2) Treatment of achalasia with one of the following procedures:
- Endoscopic balloon dilatation
- Surgical Heller myotomy
- Per-oral endoscopic myotomy (POEM)
3) Maximum total score on the GastroEsophageal Reflux Disease Questionnaire (GERDQ) of < 8.
4) No gastroesophageal symptoms after treatment.
5) Age 18-80 years.
6) Written informed consent.
Exclusion criteria
Treated achalasia patients WITH gastroesophageal reflux symptoms
- Pseudoachalasia.
- Upper gastrointestinal malignancy.
- Chagas disease.
- Peptic ulcer disease.
- Inability to stop PPI, H2-receptor antagonist or prokinetic drug for two weeks.
- Presence of an extremely dilated oesophagus body >5 cm.;Treated achalasia patients WITHOUT gastroesophageal reflux symptoms
- Pseudoachalasia.
- Upper gastrointestinal malignancy.
- Chagas disease.
- Peptic ulcer disease.
- Inability to stop PPI, H2-receptor antagonist or prokinetic drug for two weeks.
- Presence of an extremely dilated oesophagus body >5 cm.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42367.018.12 |
| OMON | NL-OMON20979 |