Achalasia Esophageal motility disorder
Conditions
Interventions
Study subjects undergo a POEM or endoscopic pneumodilatation
Per-oral endoscopic submucosal myotomy (POEM): The POEM technique is entirely
endoscopic. Using an endoscopic knife, an entry to the subm
Sponsors
Amsterdam UMC
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Newly diagnosed achalasia patients aged 7 - 18 years old with - Eckardt score > 3; - presence of a high resolution manometry pattern consistent with achalasia type 1 or 2 according to the Chicago classification (CC) V3.0 criteria - barium esophagram suggestive of achalasia
Exclusion criteria
Exclusion criteria: - Previous endoscopic or surgical treatment for achalasia - Previous surgery of the upper gastrointestinal tract - Known coagulopathy - Liver cirrhosis and/or esophageal varices - Known grade >=B esophagitis - Barrett*s esophagus - Known pregnancy at time of treatment - Stricture of the esophagus - Presence of malignant or premalignant esophageal lesions - Hiatal hernia > 1cm - Extensive, tortuous dilatation (>7cm luminal diameter, S shape) of the esophagus - Barium esophagram suggestive for other pathologies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is treatment success, defined as a 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 1 year. | — |
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 impedance manometry - Distensibility of the lower oesofageal sfincter, as measured with EndoFLIP - Inflammatory parameters in the lower oesophageal sfincter, as established based on biopsies - 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’. | — |
Countries
Australia, Belgium, Canada, Croatia, France, Israel, Netherlands, Poland, Thailand, United Kingdom, United States
Contacts
Public ContactM.P. Wijk
Amsterdam UMC
Outcome results
None listed