Back to resultsPragmatic Approach To Esophageal Dilation
Primary Purpose
Dysphagia, Swallowing Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dilation 60-Fr non stricture
Sham
Non severe stricture - dilation with 60-Fr
Non severe stricture - dilation with 46-Fr
Severe stricture - dilation with 51-Fr
Severe stricture - dilation with 42-Fr
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring Dysphagia, Swallowing Disorders, Empirical dilation, Dilation, Dysphagia score, Diet score
Eligibility Criteria
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.
Sites / Locations
- University of Louisville HospitalRecruiting
- UofL health - Jewish hospital downtown
- Louisville VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Sham Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Without stricture - dilation with 60-Fr
Without stricture - dilation with 15-Fr
Non severe stricture - dilation with 60-Fr
Non severe stricture - dilation with 46-Fr
Severe stricture - dilation with 51-Fr
Severe stricture - dilation with 42-Fr
Arm Description
Patients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator
Patients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham)
Patients with non-severe stricture on upper endoscopy will receive dilation with 60-Fr dilator
Patients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator
Patients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator
Patients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
Duration of sustained change between sessions
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
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.
Full Information
NCT ID
NCT04542551
First Posted
August 31, 2020
Last Updated
June 12, 2023
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT04542551
Brief Title
Pragmatic Approach To Esophageal Dilation
Official Title
Pragmatic Approach To Esophageal Dilation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Swallowing Disorders
Keywords
Dysphagia, Swallowing Disorders, Empirical dilation, Dilation, Dysphagia score, Diet score
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Without stricture - dilation with 60-Fr
Arm Type
Active Comparator
Arm Description
Patients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator
Arm Title
Without stricture - dilation with 15-Fr
Arm Type
Sham Comparator
Arm Description
Patients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham)
Arm Title
Non severe stricture - dilation with 60-Fr
Arm Type
Active Comparator
Arm Description
Patients with non-severe stricture on upper endoscopy will receive dilation with 60-Fr dilator
Arm Title
Non severe stricture - dilation with 46-Fr
Arm Type
Active Comparator
Arm Description
Patients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator
Arm Title
Severe stricture - dilation with 51-Fr
Arm Type
Active Comparator
Arm Description
Patients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator
Arm Title
Severe stricture - dilation with 42-Fr
Arm Type
Active Comparator
Arm Description
Patients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator
Intervention Type
Procedure
Intervention Name(s)
Dilation 60-Fr non stricture
Intervention Description
Dilation of patients with subjective dysphagia and normal endoscopy
Intervention Type
Procedure
Intervention Name(s)
Sham
Intervention Description
Sham dilator for patients with subjective dysphagia and normal endoscopy
Intervention Type
Procedure
Intervention Name(s)
Non severe stricture - dilation with 60-Fr
Intervention Description
Dilation of non severe stricture with 60-Fr dilator
Intervention Type
Procedure
Intervention Name(s)
Non severe stricture - dilation with 46-Fr
Intervention Description
Dilation of non severe stricture with 46-Fr dilator
Intervention Type
Procedure
Intervention Name(s)
Severe stricture - dilation with 51-Fr
Intervention Description
Dilation of a severe stricture with 51-Fr dilator
Intervention Type
Procedure
Intervention Name(s)
Severe stricture - dilation with 42-Fr
Intervention Description
Dilation of a severe stricture with 42-Fr dilator
Primary Outcome Measure Information:
Title
Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.
Description
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.
Time Frame
Baseline, every 8 weeks for 12 months
Title
Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.
Description
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.
Time Frame
Baseline, every 8 weeks for 12 months
Title
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.
Description
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.
Time Frame
Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Title
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.
Description
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.
Time Frame
Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Title
Achievement of complete relief of dysphagia
Description
Evaluate the number of patients in each study arm that achieve complete relief of dysphagia for the remainder of the study.
Time Frame
End of study (12 months)
Secondary Outcome Measure Information:
Title
Dilation sessions required to achieved sustainable change in dysphagia and diet score
Description
Evaluate the number of dilation sessions needed to achieve sustainable change in dysphagia and diet scores in patients with non-severe and severe stricture.
Time Frame
End of study (12 months)
Title
Duration of sustained change between sessions
Description
Evaluate the average duration between dilation sessions in patients undergoing dilation for non-severe and severe strictures.
Time Frame
Every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Title
Reduction of more than 3 sizes dilators in subsequent dilation sessions to achieve the goal dilation
Description
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.
Time Frame
Every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Ahmed Eisa, MD
Phone
4049069605
Email
meeisa01@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Nguyen, MD
Phone
8326613655
Email
vdnguy03@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Eisa, MD
Organizational Affiliation
University of Louisville School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent Nguyen, MD
Organizational Affiliation
University of Louisville School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Endashaw Omer, MD
Organizational Affiliation
University of Louisville School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Benjamin Rogers, MD
Organizational Affiliation
University of Louisville School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Eisa, MD
Facility Name
UofL health - Jewish hospital downtown
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Eisa
Facility Name
Louisville VA Medical Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Eisa, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Planning to share data throughout the intervals for which patients will be called for response and when data available for analysis.
Learn more about this trial
Pragmatic Approach To Esophageal Dilation
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