Botox or Botox With Esophageal Dilation in Patients With Achalasia

Vanderbilt University Medical Center

Status and phase: Invitation-only; Phase 4

Conditions: Achalasia

Treatments: Device: Endoscope balloon dilator; Diagnostic Test: Barium esophagram; Other: Patient reported outcomes; Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT03654066

181420

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Botulinum toxin

Active Comparator group

Description:

A one time dose of Botulinum toxin (Botox) is injected into the muscle of the LES leading to blockage of acetylcholine release from nerve endings resulting in increased relaxation.

Treatment:

Diagnostic Test: Barium esophagram

Drug: Botulinum toxin type A

Other: Patient reported outcomes

Botulinum toxin and dilation

Active Comparator group

Description:

A one time dose of Botulinum toxin (Botox) is injected into the muscle of the LES leading to blockage of acetylcholine release from nerve endings resulting in increased relaxation. Subjects will also undergo distal esophageal dilation using a 20mm through the scope balloon positioned across the LES.

Treatment:

Diagnostic Test: Barium esophagram

Drug: Botulinum toxin type A

Other: Patient reported outcomes

Device: Endoscope balloon dilator