motility disorder of the esophagus because of nerve degradation. Esophageal motility disorder and failure of LES relaxation
Conditions
Interventions
Dilation of the LES using the EsoFLIP catheter.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Between 18 and 70 years of age -Diagnosed with achalasia by absence of peristalsis and impaired relaxation of the LES (during swallow-induced relaxation a residual pressure of >=10mmHg) on standard manometry -Eckardt symptom score >3 at baseline -Eligible for standard pneumatic balloon dilation therapy
Exclusion criteria
Exclusion criteria: -Previous invasive treatment for achalasia -Pseudoachalasia -Megaesophagus (diameter of >=7 cm) -Altered anatomy of the esophagus due to surgery -Barrett*s epithelium (>M2; >C1) or any grade of dysplasia, seen during endoscopy or in a biopsy in the past six months -A history of either suspected or confirmed esophageal cancer -Confirmed eosinophilic esophagitis -Liver cirrhosis, portal hypertension and/or esophageal varices -Coagulopathy (INR>1.5, platelets
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical feasibility, defined as the percentage of successful dilations performed with this catheter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: safety (adverse events and serious adverse events) efficacy, measurements of balloon diameter and pressure at different volumes of balloon inflation, the amount of mSV and the number of patients in which there is treatment failure. | — |
Countries
Netherlands
Outcome results
None listed