Pragmatic Approach To Esophageal Dilation

Sponsor

University of Louisville (Other)

Overall Status

Recruiting

CT.gov ID

NCT04542551

Collaborator

(none)

168

Enrollment

Locations

Arms

23.2

Anticipated Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphagia Swallowing Disorders	Procedure: Dilation 60-Fr non stricture 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: Severe stricture - dilation with 42-Fr	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Pragmatic Approach To Esophageal Dilation

Actual Study Start Date :

Mar 24, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Without stricture - dilation with 60-Fr Patients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator	Procedure: Dilation 60-Fr non stricture Dilation of patients with subjective dysphagia and normal endoscopy
Sham Comparator: Without stricture - dilation with 15-Fr Patients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham)	Procedure: Sham Sham dilator for patients with subjective dysphagia and normal endoscopy
Active Comparator: Non severe stricture - dilation with 60-Fr Patients with non-severe stricture on upper endoscopy will receive dilation with 60-Fr dilator	Procedure: Non severe stricture - dilation with 60-Fr Dilation of non severe stricture with 60-Fr dilator
Active Comparator: Non severe stricture - dilation with 46-Fr Patients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator	Procedure: Non severe stricture - dilation with 46-Fr Dilation of non severe stricture with 46-Fr dilator
Active Comparator: Severe stricture - dilation with 51-Fr Patients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator	Procedure: Severe stricture - dilation with 51-Fr Dilation of a severe stricture with 51-Fr dilator
Active Comparator: Severe stricture - dilation with 42-Fr Patients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator	Procedure: Severe stricture - dilation with 42-Fr Dilation of a severe stricture with 42-Fr dilator

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
Patients with achalasia, or globus sensation.
Any accessory procedures, like esophageal stenting, excision, steroid injection, or dysphagia treatment currently being done at outside facility.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville Hospital	Louisville	Kentucky	United States	40202
2	UofL health - Jewish hospital downtown	Louisville	Kentucky	United States	40202
3	Louisville VA Medical Center	Louisville	Kentucky	United States	40206

Sponsors and Collaborators

University of Louisville

Investigators

Principal Investigator: Mohamed Eisa, MD, University of Louisville School of Medicine
Principal Investigator: Vincent Nguyen, MD, University of Louisville School of Medicine
Study Chair: Endashaw Omer, MD, University of Louisville School of Medicine
Study Chair: Benjamin Rogers, MD, University of Louisville School of Medicine