Botox or Botox With Esophageal Dilation in Patients With Achalasia



Status:Enrolling by invitation
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:May 2019
End Date:March 2023

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Trial Summary
Trial Overview
Inclusion Criteria

Prospective Single-Blinded Randomized Controlled Trial Comparing Botox or Botox With Esophageal Dilation in Patients With Achalasia

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.


Inclusion Criteria:

- Adults with known diagnosis of achalasia who are NOT candidates for definitive therapy
with pneumatic dilation, surgical myotomy, or POEM

- Patient undergoing upper endoscopy and no prior esophageal dilations or botox
injections

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
We found this trial at
1
site
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee 37232
Principal Investigator: Dhyanesh Patel, MD
Phone: 615-322-6281
?
mi
from
Nashville, TN
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