Assessing the Efficacy of Steroid Treatment of Achalasia

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Would systemic steroids be an effective treatment in early variants of achalasia?

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Prednisone

Criteria

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.