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Reflux symptoms in patients with achalasia.

Completed
Conditions
Achalasia
10017977
Oesophageal motility disorder
Registration Number
NL-OMON37315
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
40
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.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Gastroesophageal reflux episodes.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>LES pressure.<br /><br>Esophagogastric junction distensibility.<br /><br>Sensitivity to acid perfusion and distension.<br /><br>Level of esophageal stasis.<br /><br>Widt/diameter of the esophagus.</p><br>
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