Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management
Esophageal Dilation, Refractory Benign Esophageal Stricture
About this trial
This is an interventional treatment trial for Esophageal Dilation
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Other
Experimental
Standard Clinical Care Endoscopic Dilation Group
Esophageal Self-Dilation Therapy (ESDT) Group
Observational Study Group
Standard Clinical Care Endoscopic Dilation, Then ESDT
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.
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.
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
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.