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Botox or Botox With Esophageal Dilation in Patients With Achalasia
Sponsor: Vanderbilt University Medical Center
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.
Official title: Prospective Single-Blinded Randomized Controlled Trial Comparing Botox or Botox With Esophageal Dilation in Patients With Achalasia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2019-05-13
Completion Date
2026-06
Last Updated
2025-05-20
Healthy Volunteers
No
Conditions
Interventions
Botulinum toxin type A
Botox injection in the LES
Endoscope balloon dilator
Distal esophageal dilation
Patient reported outcomes
Subjects will complete two patient reported outcome measures (Eckardt and MADS).
Barium esophagram
Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium
Locations (1)
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, United States