Botox and/or Esophageal Dilation for Achalasia
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Botulinum toxin type A for treating achalasia?
Research shows that injecting botulinum toxin into the esophagus can effectively treat achalasia by helping the lower esophageal sphincter (a muscle that controls the opening between the esophagus and stomach) relax, which improves swallowing. Many patients experience improvement for 2-6 months, although repeat treatments may be needed.12345
Is Botox safe for treating achalasia?
How does the drug botulinum toxin differ from other treatments for achalasia?
Botulinum toxin is a less invasive treatment for achalasia that works by blocking nerve signals to reduce muscle pressure in the esophagus, offering a safer option with fewer complications compared to pneumatic dilation, which involves stretching the esophagus and carries a risk of perforation. However, the effects of botulinum toxin are temporary, often requiring repeat treatments every few months.1291011
What is the purpose of this trial?
This trial is testing a combination of esophageal stretching and botox injections for patients with achalasia who have other health issues. The treatment aims to make swallowing easier by both stretching the esophagus and relaxing its muscles. Botox injections have been used for treating achalasia and other esophageal motility disorders, providing temporary relief.
Research Team
Dhyanesh Patel, MD
Principal Investigator
Vanderbilt University Medical Center
Eligibility Criteria
This trial is for adults with achalasia, a rare disorder affecting esophagus movement, who can't have standard treatments like dilation or surgery. They must be undergoing routine upper endoscopy for their condition but cannot participate if they're under 18 or have had previous surgeries for reflux or peptic ulcers.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a one-time dose of Botulinum toxin (Botox) injection into the LES, with or without esophageal dilation
Follow-up
Participants are monitored for symptomatic response and dysphagia score over time
Treatment Details
Interventions
- Botulinum toxin type A
- Esophageal Dilation
Botulinum toxin type A is already approved in United States, European Union for the following indications:
- Upper limb spasticity (excluding spasticity caused by cerebral palsy)
- Chronic sialorrhea
- Upper limb spasticity
- Chronic sialorrhea
- Blepharospasm
- Cervical dystonia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor