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OpenTrials
Completed

NCT Number: NCT04542551

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Dilatation, Pathologic Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Swallowing Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louisville VA Medical Center, Louisville, Kentucky, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dilation 60-Fr non stricture

Procedure

Dilation of patients with subjective dysphagia and normal endoscopy

Sham

Procedure

Sham dilator for patients with subjective dysphagia and normal endoscopy

Non severe stricture - dilation with 60-Fr

Procedure

Dilation of non severe stricture with 60-Fr dilator

Non severe stricture - dilation with 46-Fr

Procedure

Dilation of non severe stricture with 46-Fr dilator

Severe stricture - dilation with 51-Fr

Procedure

Dilation of a severe stricture with 51-Fr dilator

Severe stricture - dilation with 42-Fr

Procedure

Dilation of a severe stricture with 42-Fr dilator

Primary outcomes

  1. Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.

    Time frame: Baseline, every 8 weeks for 12 months

    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.

  2. Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.

    Time frame: Baseline, every 8 weeks for 12 months

    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.

  3. 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.

    Time frame: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months

    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.

  4. 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.

    Time frame: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months

    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.

  5. Achievement of complete relief of dysphagia

    Time frame: End of study (12 months)

    Evaluate the number of patients in each study arm that achieve complete relief of dysphagia for the remainder of the study.

Secondary outcomes

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

    Time frame: End of study (12 months)

    Evaluate the number of dilation sessions needed to achieve sustainable change in dysphagia and diet scores in patients with non-severe and severe stricture.

  2. Duration of sustained change between sessions

    Time frame: Every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months

    Evaluate the average duration between dilation sessions in patients undergoing dilation for non-severe and severe strictures.

  3. Reduction of more than 3 sizes dilators in subsequent dilation sessions to achieve the goal dilation

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

    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.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2020
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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