Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

Mayo Clinic

Status: Completed

Conditions: Refractory Benign Esophageal Stricture; Esophageal Dilation

Treatments: Procedure: Endoscopic therapy with esophageal dilation; Device: Esophageal self-dilation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03738566

18-000246

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 4 patient groups

Standard Clinical Care Endoscopic Dilation Group

Active Comparator group

Description:

Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.

Treatment:

Procedure: Endoscopic therapy with esophageal dilation

Esophageal Self-Dilation Therapy (ESDT) Group

Active Comparator group

Description:

Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.

Treatment:

Device: Esophageal self-dilation therapy

Observational Study Group

Other group

Description:

Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.

Treatment:

Device: Esophageal self-dilation therapy

Procedure: Endoscopic therapy with esophageal dilation

Standard Clinical Care Endoscopic Dilation, Then ESDT

Experimental group

Description:

Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.

Treatment:

Device: Esophageal self-dilation therapy

Procedure: Endoscopic therapy with esophageal dilation