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Esophageal StrictureNCT04730076

Balloon Dilation Methods for Benign Esophageal Stricture

A study testing Standard Balloon Dilation and Progressive Balloon Dilation in people with Esophageal Stricture, run by Samuel H Mardini at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Esophageal Stricture
What is being tested?
Standard Balloon Dilation and Progressive Balloon Dilation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
13 Jul 2020to 1 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kentucky

    Lexington, Kentucky, 40536

Other trials in United States

About this study

Official title: Randomized Prospective Trial of Balloon Dilation Technique for Benign Esophageal Strictures.

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.

Read the detailed description

Benign esophageal strictures are a frequently encountered problem in the clinical practice of gastroenterology. The formation of benign strictures of the esophagus is believed to be caused by the production of fibrous tissue and deposition of collagen stimulated by deep esophageal ulceration or chronic inflammation. The most common cause of esophageal stricture is a peptic stricture, which is caused by reflux esophagitis. Gastroesophageal reflux disease (GERD) affects approximately 40% of adults and if left untreated 7-25% will develop a peptic stricture. Other common causes include radiation, caustic ingestions, anastomotic strictures, and eosinophilic esophagitis-associated strictures. Patients with an esophageal stricture characteristically have dysphagia (difficulty swallowing) to solid food instead of liquids. Other symptoms could include regurgitation of food and liquids, sensation that food is stuck in the chest after eating, and heartburn. Dysphagia can have a severe and deleterious impact on quality of life of these patients and lead to complications such as aspiration, weight loss and malnutrition.

According to the literature, esophageal strictures are structurally categorized into two groups: simple and complex. Simple strictures are concentric with a diameter of >12 mm or easily allow passage of a diagnostic upper endoscope. Complex strictures are usually long, asymmetric, diameter <12 mm or inability to pass an endoscope. Complex strictures are more difficult to treat and tend to be refractory despite adequate dilation therapy.

The standard management approach of benign strictures is dilation therapy. The mechanistic action of the balloon dilators is they distribute the dilating force radially and simultaneously across the entire length of the stricture. Balloon dilators can be passed through-the-scope (TTS) or over a guide-wire. Once the balloon dilator catheter is passed through the endoscope, it is positioned so that the narrowest portion of the stricture is at the center of the balloon. The dilators are typically inflated with water (or radio-opaque material if performed under fluoroscopy) to pressures that correspond to specific dilation diameters. The degree of dilation within a session should be based on the severity of the stricture by estimating the stricture diameter, followed by serial increases in the diameter of the dilating balloon. There are no data on the optimal duration the balloon should remain inflated, but national and international guidelines recommend inflation times from 30 to 60 seconds.

Balloon dilation has been the primary method for treating benign esophageal strictures for decades due to its effectiveness and safety. According to the current medical literature, about 80-90% of patients have relief of dysphagia but unfortunately, about 30-40%of patients eventually have a recurrence of dysphagia and require repeat dilation. Predictors for recurrence include the presence of a complex stricture, persistence of heartburn symptoms, presence of non-acid related strictures (radiation-induced or caustic ingestion), and eosinophilic esophagitis. Generally, the last dilator used in the previous dilation session should be used first.

There is also no consensus regarding how frequent the interval of balloon dilations should be performed. Helsema et al, conducted a retrospective study to determine the optimal target of endoscopic dilation of postsurgical esophageal strictures. Eighty-eight patients were dilated up to a maximum diameter of 16 mm and 91 patients to a diameter >16 mm. The stricture recurrence rate was 79.5 % in the 16 mm group and 68.1 %in the >16 mm group. They concluded that endoscopic dilation over 16 mm resulted in a significant prolongation of the dilation-free period in comparison with dilation up to 16 mm in patients with benign anastomotic strictures after esophagectomy. Pereira-Lima et al performed 1043 dilation sessions on 153 patients. Stricture's etiology was postsurgical in 80 patients, peptic in 37, caustic in 12, and from other causes in 11 patients. Adequate dilation was achieved in 93.5% of the patients (131 of 140). Patients with peptic strictures needed a median of three sessions to be adequately dilated during follow-up in comparison to five sessions among patients with postsurgical or caustic strictures. They concluded that endoscopic dilation is safe and effective in relieving dysphagia caused by benign strictures of different causes, although frequently repeated sessions are necessary because of stricture recurrence.

Being tested
Standard Balloon Dilation, Progressive Balloon Dilation
Keywords
balloon dilation, diameter, dysphagia
Medical subject headings
Esophageal Stenosis, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Balloon DilationProcedure or surgery

    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.

  • Progressive Balloon DilationProcedure or surgery

    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.

Study groups in NCT04730076
Study groupRoleWhat they receive
Standard Balloon DilationActive comparatorPatients in this group will receive standard balloon dilation therapy.
Receives: Procedure: Standard Balloon Dilation
Progressive Balloon DilationExperimentalPatients in this group will receive progressive balloon dilation therapy.
Receives: Procedure: Progressive Balloon Dilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 3 weeks

  3. Number of balloons

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

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2021
  2. Study start13 Jul 2020
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion1 Sep 2022 (estimated)

Why it stopped: IRB closed due to slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04730076
Sponsor's protocol ID
44391
Status last verified
Nov 2022
First submitted
25 Jan 2021
Last updated
23 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard Balloon Dilation and Progressive Balloon Dilation in people with Esophageal Stricture, run by Samuel H Mardini at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Dysphagia (time frame: 1 year (at 1, 3, 6 and 12 months follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.

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Clinical Trial NCT04730076 | AzTrials