Clinical trial NCT03738566: Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management
Official title: Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Dilation
Refractory Benign Esophageal Stricture
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects who agreed to participate in the randomized trial were randomized to standard clinical care consisting of endoscopic dilation as needed versus esophageal self-dilation therapy in a 1:1 ratio using a block randomization approach. Subjects randomized to the standard clinical care group were offered cross-over to the esophageal self-dilation therapy if they failed stand of care. Subjects who agreed to take part in in the observational prospective study either commenced ESDT or continued standard clinical care based on shared decision making with their esophageal provider.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Endoscopic Interventions
timeFrame: 6 months following serial dilation
Secondary outcomes:
measure: Length of Days Intervention Free
timeFrame: 6 months
measure: Mayo Dysphagia Questionnaire (MDQ-30) at Baseline
timeFrame: Baseline
measure: Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months
timeFrame: 12 months
measure: Clinically Significant Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeffrey Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References:
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