NCT03654066

Botox or Botox With Esophageal Dilation in Patients With Achalasia

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

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Achalasia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-13
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2018-08-31
• Last updated: 2025-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study