Botox or Botox With Esophageal Dilation in Patients With Achalasia

Overview

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.

Full Title of Study: “Prospective Single-Blinded Randomized Controlled Trial Comparing Botox or Botox With Esophageal Dilation in Patients With Achalasia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2023

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • dysphagia score
    • Time Frame: 12 months
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dhyanesh Patel, Principal Investigator – Vanderbilt University Medical Center
  • Overall Official(s)
    • Dhyanesh Patel, MD, Principal Investigator, Vanderbilt University Medical Center

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