Achalasia Oesophageal motility disorder
Conditions
Interventions
Study subjects undergo a POEM or endoscopic pneumodilatation
Per-oral endoscopic submucosal myotomy (POEM): The POEM tehcnique is entirely
endoscopic. Using an endoscopic knife, an entry to the subm
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Presence of achalasia, as shown on oesophageal manometry - Eckardt score > 3 - Age between 18-80 years - Signed written informed consent - ASA class I or II
Exclusion criteria
Exclusion criteria: - Previous endoscopic or surgical treatment for achalasia, except botulinium toxin injections - Previous surgery of the stomach or oesophagus - Patients with known coagulopathy - Presence of liver cirrhosis and/or oesophageal varices - Presence of eosinophilic oesophagitis - Presence of Barrett*s oesophagus - Pregnancy at time of treatment - Presence of a stricture of the oesophagus - Presence of malignant or premalignant oesophageal lesions - Presence of an extensive, tortuous dilated oesophageal body (S-shape) - Presence of a diverticula in the distal oesophagus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is treatment success, defined as an Eckardt score of 3 or less in the absence of the need for endoscopic or surgical retreatment and the absence of severe complications associated with treatment. The primary endpoint is measured after two years, but follow up is continued up to 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Quality of life and achalasia-specific quality of life - Stasis in the oesophagus, measured with a timed barium oesophagogram - Presence of reflux symptoms, reflux oesophagitis and excessive oesophageal acid exposure - Lower oesophageal sphincter pressure and integrative relaxation pressure (IRP4), as measured with high-resolution manometry - Complications of the treatment, defined as any unwanted events that arise following treatment and/or that are secondary to the treatment. Complications are classified as *severe* when these result in admission > 24 hours or prolongation of an already planned admission of >24 hours, admission to a medium or intensive care unit, additional endoscopic procedures, or blood transfusion or death. Other complications are classified as *mild*. - The need for endoscopic or surgical retreatment after the initial treatment session | — |
Countries
Netherlands
Outcome results
None listed