Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophageal Dilation, Refractory Benign Esophageal Stricture

Intervention / Treatment
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* Device: Esophageal self-dilation therapy
* Procedure: Endoscopic therapy with esophageal dilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Clinical Care Endoscopic Dilation Group<br>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. | Procedure: Endoscopic therapy with esophageal dilation<br>* A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.<br>|
| Active Comparator: Esophageal Self-Dilation Therapy (ESDT) Group<br>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. | Device: Esophageal self-dilation therapy<br>* 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.<br>* Other names: ESDT;|
| Other: Observational Study Group<br>Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider. | Device: Esophageal self-dilation therapy<br>* 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.<br>* Other names: ESDT;Procedure: Endoscopic therapy with esophageal dilation<br>* A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.<br>|
| Experimental: Standard Clinical Care Endoscopic Dilation, Then ESDT<br>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. | Device: Esophageal self-dilation therapy<br>* 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.<br>* Other names: ESDT;Procedure: Endoscopic therapy with esophageal dilation<br>* A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Endoscopic Interventions | 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 | 6 months following serial dilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Days Intervention Free | Number of days from start of study participation to 1st endoscopic intervention for recurrent dysphagia | 6 months | 
| Mayo Dysphagia Questionnaire (MDQ-30) at Baseline | The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being Not at all severe and 10 being Very severe | Baseline | 
| Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months | The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being Not at all severe and 10 being Very severe | 12 months | 
| Clinically Significant Adverse Events | Number of clinically significant adverse events including perforation, bleeding and pain | 12 months |