Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

Mayo Clinic26 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Dilation Refractory Benign Esophageal Stricture

Interventions

Esophageal self-dilation therapyDEVICE

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.

Endoscopic therapy with esophageal dilationPROCEDURE

A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Time frame: 6 months following serial dilation

Secondary Outcomes

Length of Days Intervention Free

Number of days from start of study participation to 1st endoscopic intervention for recurrent dysphagia

Time frame: 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"

Time frame: Baseline

Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months

Time frame: 12 months

Clinically Significant Adverse Events

Number of clinically significant adverse events including perforation, bleeding and pain

Time frame: 12 months

Data from ClinicalTrials.gov

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