Botox or Botox With Esophageal Dilation in Patients With Achalasia

Last updated: May 14, 2025
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Enrolling

Phase

4

Condition

Esophageal Disorders

Achalasia

Treatment

Barium esophagram

Endoscope balloon dilator

Patient reported outcomes

Clinical Study ID

NCT03654066
181420
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults with known diagnosis of achalasia who are NOT candidates for definitivetherapy with pneumatic dilation, surgical myotomy, or POEM

  • Patient undergoing routine care upper endoscopy for achalasia

Exclusion

Exclusion Criteria:

  • Less than 18 years old

  • Previous surgery for reflux or peptic ulcer disease

  • Significant medical conditions possibly placing subjects at risk to undergoendoscopy

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Barium esophagram
Phase: 4
Study Start date:
May 13, 2019
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Vanderbilt University Medical Center Endoscopy Laboratory

    Nashville, Tennessee 37232
    United States

    Site Not Available

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