Achalasia
Conditions
Keywords
Trouble swallowing, dysphagia, disorder of the esophagus
Brief summary
Would systemic steroids be an effective treatment in early variants of achalasia?
Interventions
DRUGApo-Prednisone Cordorol, Detasone - Prednisone
Oral prednisone (study medication) at a dose of 40mg for 1 week, then 30mg for 1 week, then 20mg for 1 week, then 10mg for 1 week, and then stop the medication.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adults ages 18-90 with a diagnosis of achalasia confirmed by findings on esophageal manometry and barium esophagogram will be eligible for the study. * Eckardt score6 greater or equal to 6 or 2 or greater for dysphagia and/or regurgitation * Symptoms less than 2 years
Exclusion criteria
* Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy and injection; * Greater than mild esophageal dilation * Type 1 achalasia as defined by the Chicago classification scheme7 and/or esophageal diameter \> 3cm; * Prior treatment for achalasia * Use of medications that might affect LES pressure such as anticholinergics or calcium channel antagonists * Symptom duration greater than 2 years * Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy * Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss * Pregnant and lactating females will be excluded as steroids are not thought safe for the fetus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with an Eckhart score ≥ 6 at 1 month | Baseline to 1 month |
Secondary
| Measure | Time frame |
|---|---|
| proportion of patients with symptomatic improvement (Eckardt sore 6 or greater) | baseline to 1 year |
Outcome results
None listed