Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

Not Applicable

Completed

Conditions: Esophageal Dilation
Refractory Benign Esophageal Stricture

Interventions: Procedure: Endoscopic therapy with esophageal dilation
Device: Esophageal self-dilation therapy

Registration Number: NCT03738566

Lead Sponsor: Mayo Clinic

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 26

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Clinical Care Endoscopic Dilation Group	Endoscopic therapy with esophageal dilation	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.
Observational Study Group	Esophageal self-dilation therapy	Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Standard Clinical Care Endoscopic Dilation, Then ESDT	Endoscopic therapy with esophageal dilation	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.
Observational Study Group	Endoscopic therapy with esophageal dilation	Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Esophageal Self-Dilation Therapy (ESDT) Group	Esophageal self-dilation therapy	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.
Standard Clinical Care Endoscopic Dilation, Then ESDT	Esophageal self-dilation therapy	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.

Primary Outcome Measures

Name	Time	Method
Number of Endoscopic Interventions	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 Outcome Measures

Name	Time	Method
Mayo Dysphagia Questionnaire (MDQ-30) at Baseline	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"
Length of Days Intervention Free	6 months	Number of days from start of study participation to 1st endoscopic intervention for recurrent dysphagia
Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months	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"
Clinically Significant Adverse Events	12 months	Number of clinically significant adverse events including perforation, bleeding and pain