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Botox or Botox With Esophageal Dilation in Patients With Achalasia

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ClinicalTrials.gov Identifier: NCT03654066
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2018
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dhyanesh Patel, Vanderbilt University Medical Center

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
Achalasia Drug: Botulinum toxin type A Device: Endoscope balloon dilator Other: Patient reported outcomes Diagnostic Test: Barium esophagram Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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 Name: 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 Name: 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




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654066


Locations
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United States, Tennessee
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Dhyanesh Patel, MD Vanderbilt University Medical Center

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Responsible Party: Dhyanesh Patel, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03654066     History of Changes
Other Study ID Numbers: 181420
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents