Assessing the Efficacy of Steroid Treatment of Achalasia
Would systemic steroids be an effective treatment in early variants of achalasia?
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
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.
Drug: Apo-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.
Primary Outcome Measures
- the proportion of patients with an Eckhart score ≥ 6 at 1 month [Baseline to 1 month]
Secondary Outcome Measures
- proportion of patients with symptomatic improvement (Eckardt sore 6 or greater) [baseline to 1 year]
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
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.
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- Mayo Clinic
- Principal Investigator: Karthik Ravi, MD, Mayo Clinic
Study Documents (Full-Text)None provided.