Pragmatic Approach To Esophageal Dilation

NCT04542551 | Completed

• 1 other identifier: 20.0632
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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.

Conditions

Dysphagia; Swallowing Disorders

Keywords

Dysphagia; Swallowing Disorders; Empirical dilation; Dilation; Dysphagia score; Diet score

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Dilation sessions required to achieved sustainable change in dysphagia and diet score

  End of study (12 months)

• Duration of sustained change between sessions

  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

  Every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year

Study Arms (6)

Without stricture - dilation with 60-Fr

ACTIVE COMPARATOR

Patients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator

Procedure: Dilation 60-Fr non stricture

Without stricture - dilation with 15-Fr

SHAM COMPARATOR

Patients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham)

Procedure: Sham

Non severe stricture - dilation with 60-Fr

ACTIVE COMPARATOR

Patients with non-severe stricture on upper endoscopy will receive dilation with 60-Fr dilator

Procedure: Non severe stricture - dilation with 60-Fr

Non severe stricture - dilation with 46-Fr

ACTIVE COMPARATOR

Patients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator

Procedure: Non severe stricture - dilation with 46-Fr

Severe stricture - dilation with 51-Fr

ACTIVE COMPARATOR

Patients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator

Procedure: Severe stricture - dilation with 51-Fr

Severe stricture - dilation with 42-Fr

ACTIVE COMPARATOR

Patients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator

Procedure: Severe stricture - dilation with 42-Fr

Interventions

Dilation 60-Fr non stricture PROCEDURE

Dilation of patients with subjective dysphagia and normal endoscopy

Without stricture - dilation with 60-Fr

Sham PROCEDURE

Sham dilator for patients with subjective dysphagia and normal endoscopy

Without stricture - dilation with 15-Fr

Non severe stricture - dilation with 60-Fr PROCEDURE

Dilation of non severe stricture with 60-Fr dilator

Non severe stricture - dilation with 60-Fr

Non severe stricture - dilation with 46-Fr PROCEDURE

Dilation of non severe stricture with 46-Fr dilator

Non severe stricture - dilation with 46-Fr

Severe stricture - dilation with 51-Fr PROCEDURE

Dilation of a severe stricture with 51-Fr dilator

Severe stricture - dilation with 51-Fr

Severe stricture - dilation with 42-Fr PROCEDURE

Dilation of a severe stricture with 42-Fr dilator

Severe stricture - dilation with 42-Fr

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (3)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

UofL health - Jewish hospital downtown

Louisville, Kentucky, 40202, United States

Location

Louisville VA Medical Center

Louisville, Kentucky, 40206, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Dilatation, Pathologic

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen McClave, MD

  University of Louisville School of Medicine

  PRINCIPAL INVESTIGATOR

• Benjamin Rogers, MD

  University of Louisville School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 9, 2020
• Study Start: March 24, 2021
• Primary Completion: October 17, 2023
• Study Completion: December 15, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (3)