Botox or Botox With Esophageal Dilation in Patients With Achalasia

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT03654066
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Achalasia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Botulinum toxin type A — DRUG
    Botox injection in the LES
  • 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

Study Details

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.

Key Dates

Start date
May 13, 2019
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Botulinum toxin
    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.
  • Active Comparator: Botulinum toxin and dilation
    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.

Primary Outcome Measure

dysphagia score [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical Center Endoscopy LaboratoryNashvilleTennessee37232-

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Vanderbilt University Medical Center Endoscopy Laboratory· Nashville, TN

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