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

NCT03654066 Phase 4 ENROLLING_BY_INVITATION

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.

Details

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 4
Status	ENROLLING_BY_INVITATION
Enrolment	50
Start date	2019-05-13
Completion	2026-06

Conditions

• Achalasia

Interventions

• Botulinum toxin type A
• Endoscope balloon dilator
• Patient reported outcomes
• Barium esophagram

Primary outcomes

• 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).

Countries

United States