Botox or Botox With Esophageal Dilation in Patients With Achalasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Botulinum toxin type A, Endoscope balloon dilator, Patient reported outcomes, Barium esophagram.
- Who it may be relevant to
- Registry conditions: Achalasia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Single-Blinded Randomized Controlled Trial Comparing Botox or Botox With Esophageal Dilation in Patients With Achalasia
Overview
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
- Drug Botulinum toxin type A
Botox injection in the LES - Device Endoscope balloon dilator
Distal esophageal dilation - Other Patient reported outcomes
Subjects will complete two patient reported outcome measures (Eckardt and MADS). - Diagnostic test Barium esophagram
Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium
Primary outcome measures
- dysphagia score [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Vanderbilt University Medical Center Endoscopy Laboratory — Nashville
Identifiers
NCT: NCT03654066 · 181420