Achalasia
Conditions
Brief summary
Achalasia is a rare esophageal motility disorder. Treatment of achalasia is aimed toward palliation of symptoms. These include botox injections to the lower esophageal sphincter (LES), pneumatic dilation, surgical myotomy, and per-oral endoscopic myotomy (POEM). Botox injections are frequently used for patients that have significant comorbidities. The primary aim of this study is to assess symptomatic response of patient with achalasia to esophageal dilation and botox injection to the LES compared to standard therapy of only botox injection.
Interventions
DRUGBotulinum toxin type A
Botox injection in the LES
DEVICEEndoscope balloon dilator
Distal esophageal dilation
OTHERPatient reported outcomes
Subjects will complete two patient reported outcome measures (Eckardt and MADS).
DIAGNOSTIC_TESTBarium esophagram
Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with known diagnosis of achalasia who are NOT candidates for definitive therapy with pneumatic dilation, surgical myotomy, or POEM * Patient undergoing routine care upper endoscopy for achalasia
Exclusion criteria
* Less than 18 years old * Previous surgery for reflux or peptic ulcer disease * Significant medical conditions possibly placing subjects at risk to undergo endoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dysphagia score | 12 months | Dysphagia score as measured by patient reported outcomes will be used to compare the two groups. The scale runs from 0 (no symptoms) to 100 (severe symptoms). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDhyanesh Patel, MD
Vanderbilt University Medical Center
Outcome results
None listed