Pragmatic Approach To Esophageal Dilation

Dysphagia Clinical Trial

Official title:

Pragmatic Approach To Esophageal Dilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542551
• Other study ID #: 20.0632
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 15, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with esophageal dysphagia who are 18 years old or older.

2. Patients with dysphagia undergoing Esophagogastroduodenoscopy (EGD).

3. Patients who are able to provide consent for the study.

4. Patients with known esophageal stricture that may have or may not have been dilated before.

Exclusion Criteria:

1. Patients with malignant stricture.

2. Pregnant women.

3. Patients with a personal history of esophageal perforation.

4. Patients with achalasia, or globus sensation.

5. Any accessory procedures, like esophageal stenting, excision, steroid injection, or dysphagia treatment currently being done at outside facility.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Swallowing Disorders

Intervention

Procedure:
• Dilation 60-Fr non stricture
Dilation of patients with subjective dysphagia and normal endoscopy
• Sham
Sham dilator for patients with subjective dysphagia and normal endoscopy
• Non severe stricture - dilation with 60-Fr
Dilation of non severe stricture with 60-Fr dilator
• Non severe stricture - dilation with 46-Fr
Dilation of non severe stricture with 46-Fr dilator
• Severe stricture - dilation with 51-Fr
Dilation of a severe stricture with 51-Fr dilator
• Severe stricture - dilation with 42-Fr
Dilation of a severe stricture with 42-Fr dilator

Locations

Country	Name	City	State
United States	Louisville VA Medical Center	Louisville	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky
United States	UofL health - Jewish hospital downtown	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.	Evaluate the change in dysphagia (the dysphagia score is used to assess for severity of dysphagia, score ranges from 0 to 5 with the higher score indicates greater degree of severity) in patients without strictures undergoing empiric dilation.	Baseline, every 8 weeks for 12 months
Primary	Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.	Evaluate the change in diet score (the diet score is used to assess the ability of the patient to tolerate food, score ranges from 0 to 5 with the higher score indicates inability to eat) in patients without strictures undergoing empiric dilation.	Baseline, every 8 weeks for 12 months
Primary	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.	Evaluate the change in dysphagia (the dysphagia score is used to assess for severity of dysphagia, score ranges from 0 to 5 with the higher score indicates greater degree of severity) 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.	Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Primary	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.	Evaluate the change in diet score (the diet score is used to assess the ability of the patient to tolerate food, score ranges from 0 to 5 with the higher score indicates inability to eat) 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.	Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Primary	Achievement of complete relief of dysphagia	Evaluate the number of patients in each study arm that achieve complete relief of dysphagia for the remainder of the study.	End of study (12 months)
Secondary	Dilation sessions required to achieved sustainable change in dysphagia and diet score	Evaluate the number of dilation sessions needed to achieve sustainable change in dysphagia and diet scores in patients with non-severe and severe stricture.	End of study (12 months)
Secondary	Duration of sustained change between sessions	Evaluate the average duration between dilation sessions in patients undergoing dilation for non-severe and severe strictures.	Every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Secondary	Reduction of more than 3 sizes dilators in subsequent dilation sessions to achieve the goal dilation	Evaluate if more than 3 size reduction from target diameter is needed as a result of tactile resistance for subsequent dilation sessions in patients undergoing dilation for non-severe and severe stricture.	Every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year