CompletedNot Applicable

Pragmatic Approach To Esophageal Dilation

United States34 participantsStarted 2021-03-24

Plain-language summary

The purpose of this study is to better understand the role of a technique called esophageal dilation in patients who complain of trouble swallowing. In patients with esophageal stricture we want to determine if the size of the esophageal dilator makes a difference in symptoms and outcomes. In patients who do not have an obvious esophageal stricture we want to determine if esophageal dilation is an effective therapy in these patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with esophageal dysphagia who are 18 years old or older.
. Patients with dysphagia undergoing Esophagogastroduodenoscopy (EGD).
. Patients who are able to provide consent for the study.
. Patients with known esophageal stricture that may have or may not have been dilated before.

Exclusion criteria

. Patients with malignant stricture.
. Pregnant women.
. Patients with a personal history of esophageal perforation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.

Timeframe: Baseline, every 8 weeks for 12 months

Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.

Timeframe: Baseline, every 8 weeks for 12 months

Change in subjective symptoms of dysphagia in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture. As measured by dysphagia score.

Timeframe: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months

Change in ability to tolerate diet in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture. As measured by diet score.

Timeframe: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months

Achievement of complete relief of dysphagia

Timeframe: End of study (12 months)

Trial details

NCT IDNCT04542551

SponsorUniversity of Louisville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-17

View on ClinicalTrials.gov More Dysphagia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with esophageal dysphagia who are 18 years old or older.
. Patients with dysphagia undergoing Esophagogastroduodenoscopy (EGD).
. Patients who are able to provide consent for the study.
. Patients with known esophageal stricture that may have or may not have been dilated before.

Exclusion criteria

. Patients with malignant stricture.
. Pregnant women.
. Patients with a personal history of esophageal perforation.

What they're measuring

Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.

Timeframe: Baseline, every 8 weeks for 12 months

Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.

Timeframe: Baseline, every 8 weeks for 12 months

Timeframe: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months

Change in ability to tolerate diet in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture. As measured by diet score.

Timeframe: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months

Achievement of complete relief of dysphagia

Timeframe: End of study (12 months)