Botox or Botox With Esophageal Dilation in Patients With Achalasia

Study Overview
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Brief Summary
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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
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Prospective Single-Blinded Randomized Controlled Trial Comparing Botox or Botox With Esophageal Dilation in Patients With Achalasia

Conditions
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Achalasia

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Device: Endoscope balloon dilator
* Other: Patient reported outcomes
* Diagnostic Test: Barium esophagram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum toxin<br>A one time dose of Botulinum toxin (Botox) is injected into the muscle of the LES leading to blockage of acetylcholine release from nerve endings resulting in increased relaxation. | Drug: Botulinum toxin type A<br>* Botox injection in the LES<br>* Other names: Botox;Other: Patient reported outcomes<br>* Subjects will complete two patient reported outcome measures (Eckardt and MADS).<br>Diagnostic Test: Barium esophagram<br>* Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium<br>|
| Active Comparator: Botulinum toxin and dilation<br>A one time dose of Botulinum toxin (Botox) is injected into the muscle of the LES leading to blockage of acetylcholine release from nerve endings resulting in increased relaxation. Subjects will also undergo distal esophageal dilation using a 20mm through the scope balloon positioned across the LES. | Drug: Botulinum toxin type A<br>* Botox injection in the LES<br>* Other names: Botox;Device: Endoscope balloon dilator<br>* Distal esophageal dilation<br>Other: Patient reported outcomes<br>* Subjects will complete two patient reported outcome measures (Eckardt and MADS).<br>Diagnostic Test: Barium esophagram<br>* Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dysphagia score | 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). | 12 months |