Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

May 22, 2023 updated by: Jeffrey A Alexander, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Days Intervention Free
Time Frame: 6 months
Number of days from start of study participation to 1st endoscopic intervention for recurrent dysphagia
6 months
Mayo Dysphagia Questionnaire (MDQ-30) at Baseline
Time Frame: 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
Time Frame: 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
Time Frame: 12 months
Number of clinically significant adverse events including perforation, bleeding and pain
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Jeffrey Alexander, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2018

Primary Completion (Actual)

July 2, 2021

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-000246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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