Pragmatic Approach To Esophageal Dilation

University of Louisville (UOFL)

Status: Completed

Conditions: Dysphagia; Swallowing Disorders

Treatments: Procedure: Sham; Procedure: Non severe stricture - dilation with 60-Fr; Procedure: Dilation 60-Fr non stricture; Procedure: Severe stricture - dilation with 51-Fr; Procedure: Severe stricture - dilation with 42-Fr; Procedure: Non severe stricture - dilation with 46-Fr

Study type: Interventional

Funder types: Other

Identifiers

NCT04542551

20.0632

Details and patient eligibility

About

The purpose of this study is to better understand the role of a technique called esophageal dilation in patients who complain of trouble swallowing. In patients with esophageal stricture we want to determine if the size of the esophageal dilator makes a difference in symptoms and outcomes. In patients who do not have an obvious esophageal stricture we want to determine if esophageal dilation is an effective therapy in these patients.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with esophageal dysphagia who are 18 years old or older.
2. Patients with dysphagia undergoing Esophagogastroduodenoscopy (EGD).
3. Patients who are able to provide consent for the study.
4. Patients with known esophageal stricture that may have or may not have been dilated before.

Exclusion criteria

1. Patients with malignant stricture.
2. Pregnant women.
3. Patients with a personal history of esophageal perforation.
4. Patients with achalasia, or globus sensation.
5. Any accessory procedures, like esophageal stenting, excision, steroid injection, or dysphagia treatment currently being done at outside facility.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 6 patient groups

Without stricture - dilation with 60-Fr

Active Comparator group

Description:

Patients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator

Treatment:

Procedure: Dilation 60-Fr non stricture

Without stricture - dilation with 15-Fr

Sham Comparator group

Description:

Patients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham)

Treatment:

Procedure: Sham

Non severe stricture - dilation with 60-Fr

Active Comparator group

Description:

Patients with non-severe stricture on upper endoscopy will receive dilation with 60-Fr dilator

Treatment:

Procedure: Non severe stricture - dilation with 60-Fr

Non severe stricture - dilation with 46-Fr

Active Comparator group

Description:

Patients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator

Treatment:

Procedure: Non severe stricture - dilation with 46-Fr

Severe stricture - dilation with 51-Fr

Active Comparator group

Description:

Patients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator

Treatment:

Procedure: Severe stricture - dilation with 51-Fr

Severe stricture - dilation with 42-Fr

Active Comparator group

Description:

Patients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator

Treatment:

Procedure: Severe stricture - dilation with 42-Fr