Assessing the Efficacy of Steroid Treatment of Achalasia
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-009825
NCT ID: NCT01903486
Sponsor Protocol Number: 12-009825
About this study
Would systemic steroids be an effective treatment in early variants of achalasia?
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Karthik Ravi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available