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OpenTrials
Completed

NCT Number: NCT03738566

Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophageal self-dilation therapy

Device

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

Endoscopic therapy with esophageal dilation

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Length of Days Intervention Free

    Time frame: 6 months

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

  2. 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"

  3. 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"

  4. Clinically Significant Adverse Events

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Nov 13, 2018
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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