Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2021-03-24
2023-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Severe stricture - dilation with 42-Fr
Patients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator
Severe stricture - dilation with 42-Fr
Dilation of a severe stricture with 42-Fr dilator
Without stricture - dilation with 60-Fr
Patients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator
Dilation 60-Fr non stricture
Dilation of patients with subjective dysphagia and normal endoscopy
Without stricture - dilation with 15-Fr
Patients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham)
Sham
Sham dilator for patients with subjective dysphagia and normal endoscopy
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 60-Fr
Dilation of non severe stricture with 60-Fr dilator
Non severe stricture - dilation with 46-Fr
Patients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator
Non severe stricture - dilation with 46-Fr
Dilation of non severe stricture with 46-Fr dilator
Severe stricture - dilation with 51-Fr
Patients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator
Severe stricture - dilation with 51-Fr
Dilation of a severe stricture with 51-Fr dilator
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of Louisville
OTHER
Responsible Party
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Stephen McClave
MD, Professor
Principal Investigators
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Stephen McClave, MD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville School of Medicine
Benjamin Rogers, MD
Role: STUDY_CHAIR
University of Louisville School of Medicine
Locations
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University of Louisville Hospital
Louisville, Kentucky, United States
UofL health - Jewish hospital downtown
Louisville, Kentucky, United States
Louisville VA Medical Center
Louisville, Kentucky, United States
Countries
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Other Identifiers
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20.0632
Identifier Type: -
Identifier Source: org_study_id
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