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OpenTrials
Enrolling by Invitation

NCT Number: NCT03654066

Botox or Botox With Esophageal Dilation in Patients With Achalasia

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.

Enrolling by Invitation

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Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt University Medical Center Endoscopy Laboratory

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Botox injection in the LES

Other names: Botox

Endoscope balloon dilator

Device

Distal esophageal dilation

Patient reported outcomes

Other

Subjects will complete two patient reported outcome measures (Eckardt and MADS).

Barium Esophagram

Diagnostic Test

Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium

Primary outcomes

  1. dysphagia score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2018
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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