NCT03738566

Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to see which treatment is more effective in improving the difficulty of swallowing. Researchers are comparing self-dilation to endoscopic dilation.

Detailed description

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.

Conditions

• Esophageal Dilation
• Refractory Benign Esophageal Stricture

Interventions

Type	Name	Description
DEVICE	Esophageal self-dilation therapy	Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.
PROCEDURE	Endoscopic therapy with esophageal dilation	A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.

Timeline

• Start date: 2018-11-21
• Primary completion: 2021-07-02
• Completion: 2022-05-15
• First posted: 2018-11-13
• Last updated: 2023-05-24
• Results posted: 2023-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study