Botox or Botox With Esophageal Dilation in Patients With Achalasia

Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03654066
• Other study ID #: 181420
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: May 13, 2019
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center Endoscopy Laboratory	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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