Botox or Botox With Esophageal Dilation in Patients With Achalasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Achalasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type DRUG

Botox injection in the LES

Patient reported outcomes

Intervention Type OTHER

Subjects will complete two patient reported outcome measures (Eckardt and MADS).

Barium esophagram

Intervention Type DIAGNOSTIC_TEST

Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium

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.

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type DRUG

Botox injection in the LES

Endoscope balloon dilator

Intervention Type DEVICE

Distal esophageal dilation

Patient reported outcomes

Intervention Type OTHER

Subjects will complete two patient reported outcome measures (Eckardt and MADS).

Barium esophagram

Intervention Type DIAGNOSTIC_TEST

Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium

Interventions

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Botulinum toxin type A

Botox injection in the LES

Intervention Type DRUG

Endoscope balloon dilator

Distal esophageal dilation

Intervention Type DEVICE

Patient reported outcomes

Subjects will complete two patient reported outcome measures (Eckardt and MADS).

Intervention Type OTHER

Barium esophagram

Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Botox

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No