Reflux symptoms in patients with achalasia.
- Conditions
- Achalasia10017977Oesophageal 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
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.
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
Name Time Method <p>Gastroesophageal reflux episodes.</p><br>
- Secondary Outcome Measures
Name Time Method <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>