Pragmatic Approach To Esophageal Dilation

Not Applicable

Completed

• Conditions: Dysphagia; Swallowing Disorders
• Interventions: Procedure: Sham; Procedure: Non severe stricture - dilation with 60-Fr; Procedure: Non severe stricture - dilation with 46-Fr; Procedure: Severe stricture - dilation with 51-Fr; Procedure: Dilation 60-Fr non stricture; Procedure: Severe stricture - dilation with 42-Fr

• Registration Number: NCT04542551
• Lead Sponsor: University of Louisville

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-09
• Study Start: 2021-03-24
• Primary Completion: 2023-10-17
• Study Completion: 2023-12-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without stricture - dilation with 15-Fr	Sham	Patients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham)
Non severe stricture - dilation with 60-Fr	Non severe stricture - dilation with 60-Fr	Patients with non-severe stricture on upper endoscopy will receive dilation with 60-Fr dilator
Non severe stricture - dilation with 46-Fr	Non severe stricture - dilation with 46-Fr	Patients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator
Severe stricture - dilation with 51-Fr	Severe stricture - dilation with 51-Fr	Patients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator
Without stricture - dilation with 60-Fr	Dilation 60-Fr non stricture	Patients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator
Severe stricture - dilation with 42-Fr	Severe stricture - dilation with 42-Fr	Patients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator

Primary Outcome Measures

Name	Time	Method
Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.	Baseline, every 8 weeks for 12 months	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.
Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.	Baseline, every 8 weeks for 12 months	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.
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.	Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months	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.
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.	Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months	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.
Achievement of complete relief of dysphagia	End of study (12 months)	Evaluate the number of patients in each study arm that achieve complete relief of dysphagia for the remainder of the study.

Secondary Outcome Measures

Name	Time	Method
Dilation sessions required to achieved sustainable change in dysphagia and diet score	End of study (12 months)	Evaluate the number of dilation sessions needed to achieve sustainable change in dysphagia and diet scores in patients with non-severe and severe stricture.
Duration of sustained change between sessions	Every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months	Evaluate the average duration between dilation sessions in patients undergoing dilation for non-severe and severe strictures.
Reduction of more than 3 sizes dilators in subsequent dilation sessions to achieve the goal dilation	Every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year	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.

Trial Locations

Locations (3)

UofL health - Jewish hospital downtown; 🇺🇸 Louisville, Kentucky, United States

Louisville VA Medical Center; 🇺🇸 Louisville, Kentucky, United States

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States