Clinical trial NCT04542551: Pragmatic Approach To Esophageal Dilation
Official title: Pragmatic Approach To Esophageal Dilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Swallowing Disorders
Keywords: Dysphagia
Swallowing Disorders
Empirical dilation
Dilation
Dysphagia score
Diet score
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.
timeFrame: Baseline, every 8 weeks for 12 months
measure: Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.
timeFrame: Baseline, every 8 weeks for 12 months
measure: 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.
timeFrame: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
measure: 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.
timeFrame: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
measure: Achievement of complete relief of dysphagia
timeFrame: End of study (12 months)
Secondary outcomes:
measure: Dilation sessions required to achieved sustainable change in dysphagia and diet score
timeFrame: End of study (12 months)
measure: Duration of sustained change between sessions
timeFrame: Every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
measure: Reduction of more than 3 sizes dilators in subsequent dilation sessions to achieve the goal dilation
timeFrame: Every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Louisville
country: United States
facility: UofL health - Jewish hospital downtown
state: Kentucky
city: Louisville
country: United States
facility: Louisville VA Medical Center
state: Kentucky
Study officials:
affiliation: University of Louisville School of Medicine
name: Stephen McClave, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Louisville School of Medicine
name: Benjamin Rogers, MD
role: STUDY_CHAIR
References: