esophageal achalasia
Conditions
Brief summary
Presence of pathological acid reflux according to the Lyon 2018 criteria (26) at 6 months: This is a composite endpoint presence of: - Esophagitis grade C or D according to the Los Angeles classification. And / or - Acid exposure >6% on 24-hour esophageal pH-metry.
Detailed description
Presence of pathologic acid reflux according to the 2018 Lyon criteria (26) at 12 months: A) Esophagitis grade C or D B) Acid exposure >6% at 24-hour pH impedancemetry, Score aux questionnaires de qualité de vie : A) WHOQOL-BREF B) GERD HRQL, Quantity of Lansoprazole consumed (Number of boxes consumed): generic form, Occurrence of an adverse reaction, Post POEM dysphagia assessment: Eckardt score >3, Assessment of pH-impedancemetry profile at 6 and 12 months defined by Rome IV criteria (Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal).
Interventions
DRUGLansoprazole 30mg Orodispersible Tablets
Sponsors
CHU de Nimes
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of pathological acid reflux according to the Lyon 2018 criteria (26) at 6 months: This is a composite endpoint presence of: - Esophagitis grade C or D according to the Los Angeles classification. And / or - Acid exposure >6% on 24-hour esophageal pH-metry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Presence of pathologic acid reflux according to the 2018 Lyon criteria (26) at 12 months: A) Esophagitis grade C or D B) Acid exposure >6% at 24-hour pH impedancemetry, Score aux questionnaires de qualité de vie : A) WHOQOL-BREF B) GERD HRQL, Quantity of Lansoprazole consumed (Number of boxes consumed): generic form, Occurrence of an adverse reaction, Post POEM dysphagia assessment: Eckardt score >3, Assessment of pH-impedancemetry profile at 6 and 12 months defined by Rome IV criteria (Acid Reflux, Esophageal Hypersensitivity, Functional Pyrosis, Normal). | — |
Countries
France
Outcome results
None listed