Clincosm LogoSign in Get a demo

Botox or Botox With Esophageal Dilation in Patients With Achalasia

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03654066
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
48.6
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Botulinum toxin type A
  • Device: Endoscope balloon dilator
  • Other: Patient reported outcomes
  • Diagnostic Test: Barium esophagram
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Prospective Single-Blinded Randomized Controlled Trial Comparing Botox or Botox With Esophageal Dilation in Patients With Achalasia
Actual Study Start Date :
May 13, 2019
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Botulinum toxin type A
Botox injection in the LES
Other Names:
  • Botox

    • 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
    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.

    Drug: Botulinum toxin type A
    Botox injection in the LES
    Other Names:
  • Botox

    • 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

    Outcome Measures

    Primary Outcome Measures

    1. dysphagia score [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt University Medical Center Endoscopy Laboratory Nashville Tennessee United States 37232

    Sponsors and Collaborators

    • Vanderbilt University Medical Center

    Investigators

    • Principal Investigator: Dhyanesh Patel, MD, Vanderbilt University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dhyanesh Patel, Principal Investigator, Vanderbilt University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03654066
    Other Study ID Numbers:
    • 181420
    First Posted:
    Aug 31, 2018
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Esophageal Achalasia
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of May 4, 2022