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.
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.
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.
- Conditions
- Esophageal Stricture
- 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 group | Role | What they receive |
|---|---|---|
| Standard Balloon Dilation | Active comparator | Patients in this group will receive standard balloon dilation therapy. Receives: Procedure: Standard Balloon Dilation |
| Progressive Balloon Dilation | Experimental | Patients 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.
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)
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
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.
- First posted29 Jan 2021
- Study start13 Jul 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Why it stopped: IRB closed due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Samuel H Mardini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samuel H Mardini, University of Kentucky
- Investigators
- Samuel H Mardini, MD, Principal investigator, University of Kentucky
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Trial of Balloon Dilation Technique for Benign Esophageal Strictures.
- ClinicalTrials.gov ID
- NCT04730076
- Acronym / sponsor ID
- 44391
- Conditions
- Esophageal Stricture
- Keywords
- balloon dilation, diameter, dysphagia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB closed due to slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samuel H MardiniUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Balloon Dilation | Active comparator | Procedure: Standard Balloon DilationPatients in this group will receive standard balloon dilation therapy. |
| Progressive Balloon Dilation | Experimental | Procedure: Progressive Balloon DilationPatients in this group will receive progressive balloon dilation therapy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Balloon DilationThe 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. | Procedure or surgery | Standard Balloon Dilation |
| Progressive Balloon DilationIn 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. | Procedure or surgery | Progressive Balloon Dilation |
Primary outcome
Change in Dysphagia
Time frame: 1 year (at 1, 3, 6 and 12 months follow-up)
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.
Number of endoscopic dilation sessions
Time frame: 3 weeks
The number of endoscopic dilation sessions needed to achieve clinical success as defined by endoscopic and clinical resolution of dysphagia symptoms.
Number of balloons
Time frame: 3 weeks
The number of balloons needed to achieve clinical success as defined by endoscopic and clinical resolution of dysphagia symptoms.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel H Mardini, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
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.