Pragmatic Approach To Esophageal Dilation

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.

Study Overview

• Status: Completed
• Conditions: Dysphagia; Swallowing Disorders
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen McClave, MD; Phone Number: 5028527963; Email: stephen.mcclave@louisville.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital
    • Louisville, Kentucky, United States, 40202
      • UofL health - Jewish hospital downtown
    • Louisville, Kentucky, United States, 40206
      • Louisville VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, every 8 weeks for 12 months
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.	Baseline, every 8 weeks for 12 months
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.	Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
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.	Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
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.	End of study (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	End of study (12 months)
Duration of sustained change between sessions	Evaluate the average duration between dilation sessions in patients undergoing dilation for non-severe and severe strictures.	Every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
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.	Every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Study Chair: Benjamin Rogers, MD, University of Louisville School of Medicine; Principal Investigator: Stephen McClave, MD, University of Louisville School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Dysphagia; Swallowing Disorders; Dilation; Empirical dilation; Dysphagia score; Diet score
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Deglutition Disorders; Dilatation, Pathologic
• Other Study ID Numbers: 20.0632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Planning to share data throughout the intervals for which patients will be called for response and when data available for analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No