Balloon Dilation Methods for Benign Esophageal Stricture

NCT04730076 | Withdrawn

• 1 other identifier: 44391
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is the first head to head, prospective, randomized, double-blind clinical trial comparing two different approaches of balloon dilation (standard versus progressive dilation) for benign esophageal strictures. A retrospective study on patients with benign esophageal strictures that underwent balloon dilation using the proposed technique found considerable symptomatic improvement in dysphagia. The proposed balloon dilation method is a novel approach that will require fewer sessions of dilation and use fewer balloon dilation catheters to achieve a maximum balloon diameter of 18mm and result in a significant symptomatic improvement.

Conditions

Esophageal Stricture

Keywords

balloon dilation; diameter; dysphagia

Outcome Measures

Primary Outcomes (3)

• Change in Dysphagia

  Dysphagia will be measured using a 10-pt Likert scale in response to the question "In the last 7 days how would you rate the severity of your trouble swallowing." Lower scores indicate less difficulty swallowing.

  1 year (at 1, 3, 6 and 12 months follow-up)

• Number of endoscopic dilation sessions

  The number of endoscopic dilation sessions needed to achieve clinical success as defined by endoscopic and clinical resolution of dysphagia symptoms.

  3 weeks

• Number of balloons

  The number of balloons needed to achieve clinical success as defined by endoscopic and clinical resolution of dysphagia symptoms.

  3 weeks

Study Arms (2)

Standard Balloon Dilation

ACTIVE COMPARATOR

Patients in this group will receive standard balloon dilation therapy.

Procedure: Standard Balloon Dilation

Progressive Balloon Dilation

EXPERIMENTAL

Patients in this group will receive progressive balloon dilation therapy.

Procedure: Progressive Balloon Dilation

Interventions

Standard Balloon Dilation PROCEDURE

The standard approach involves a gradual balloon dilation where the balloon is inflated then held at each balloon size for 30-60 seconds then inflated to the next largest balloon diameter size and repeated to the maximum diameter size of that catheter. The dilation session will be repeated as frequently and as many times as needed to achieve the balloon diameter size of 18mm at the discretion of the endoscopist.

Standard Balloon Dilation

Progressive Balloon Dilation PROCEDURE

In the progressive approach, the balloon is continuously inflated over the course of 3-5 minutes starting at the smallest to the largest balloon diameter depending of the balloon catheter used. The dilation will be repeated every 2-3 weeks (total of 2-3 sessions). At the next endoscopic procedure, the balloon diameter used will be the next size up based on previous session.

Progressive Balloon Dilation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• more than 18 years old
• symptoms of dysphagia (difficulty swallowing) due to a benign esophageal stricture
• willing to be randomized to either arm of the study.

You may not qualify if:

• less than 18 years of age
• malignant esophageal stricture
• stricture located in the gastrointestinal tract other than the esophagus
• any benign or malignant stricture regardless of location in which the patient had previous mechanical or balloon dilation
• diagnosis of achalasia
• currently pregnant

Sponsors & Collaborators

• Samuel H Mardini: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Esophageal Stenosis; Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Samuel H Mardini, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: July 13, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)