Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:November 21, 2018
End Date:November 2020

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Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management: Randomized Controlled Trial

Among patients with refractory benign esophageal stricture (RBES) who were treated
endoscopically, we hypothesized the following:

1. Compared to a endoscopy as needed approach, esophageal self -dilation therapy (ESDT)
decreases the number of endoscopic dilation, prolong dysphagia free interval

2. Esophageal self -dilation therapy is safe and well tolerated therapy

3. ESDT significantly lower the health cost in managing refractory esophageal stricture

Benign esophageal strictures can be challenging condition to treat. The mainstay of treatment
is endoscopic dilations. However, 30 to 40% of these strictures recur despite rigorous
dilations. Although a consensus definition does not exist, a stricture is typically termed as
a refractory benign esophageal stricture (RBES), when there is a failure to maintain luminal
patency after at least 5 endoscopic dilations.

Patients with RBES are extremely difficult to manage and the current armamentarium includes
repeated endoscopic dilations, corticosteroid or mitomycin C injections, incisional therapy,
and/ or temporary stent placement. These procedures are costly, their efficacy can be
short-lived, and are associated with great burden both for the patient and clinician.

Esophageal self -dilation therapy (ESDT) is where the patient learns to pass a polyvinyl
dilator orally on a routine basis. In past, smaller studies, ESDT appears to be effective for
RBES, reducing the number of endoscopic dilations from an average of 21.7 to an average of 1.

Inclusion Criteria:

- 18 years of age or older

- Refractory benign esophageal stricture defined as an esophageal stricture with
persistent dysphagia despite undergoing 5 endoscopic dilations within a 1 year period.
Persistent dysphagia will be considered if patients has solid food dysphagia at least
once a week

Exclusion Criteria:

- Patient with malignant esophageal stricture

- Angulated stricture which prevents safe passage of Maloney dilator in office setting

- In ability to achieve an esophageal diameter of 10 mm with endoscopic dilation

- Known significant esophageal motor disorder (i.e. achalasia, aperistalsis, functional
obstruction, jackhammer, distal esophageal spasm)*

- The presence of esophageal stent

- Inability to learn self-dilation secondary to blindness or cognitive dysfunction

- Use of chronic anticoagulants
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Rochester, Minnesota 55905
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