Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Number of Endoscopic Interventions
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard Clinical Care Endoscopic Dilation Group
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.
Intervention: Endoscopic therapy with esophageal dilation (Procedure)
Esophageal Self-Dilation Therapy (ESDT) Group
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.
Intervention: Esophageal self-dilation therapy (Device)
Observational Study Group
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Intervention: Esophageal self-dilation therapy (Device)
Observational Study Group
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Intervention: Endoscopic therapy with esophageal dilation (Procedure)
Standard Clinical Care Endoscopic Dilation, Then ESDT
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.
Intervention: Esophageal self-dilation therapy (Device)
Standard Clinical Care Endoscopic Dilation, Then ESDT
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.
Intervention: Endoscopic therapy with esophageal dilation (Procedure)
Outcomes
Primary Outcomes
Number of Endoscopic Interventions
Time Frame: 6 months following serial dilation
Number of endoscopies required in a 6 month interval in subjects who achieved at least a 10-12 mm esophageal diameter during serial dilation for refractory benign esophageal stricture (RBES) and were subsequently treated with ESDT versus standard clinical care
Secondary Outcomes
- Mayo Dysphagia Questionnaire (MDQ-30) at Baseline(Baseline)
- Length of Days Intervention Free(6 months)
- Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months(12 months)
- Clinically Significant Adverse Events(12 months)
Investigators
Jeffrey A Alexander
Principal Investigator
Mayo Clinic