Esophageal StrictureNCT07560462
Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.
A study testing Budesonide intervention in people with Esophageal Stricture, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Endoscopic balloon dilatation (EBD) is a common therapeutic procedure performed for esophageal strictures. While the etiologies of esophageal strictures are numerous - including congenital strictures, caustic injuries and eosinophilic esophagitis (EoE) -anastomotic strictures following esophageal atresia and… Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Esophageal Stricture
- What is being tested?
- Budesonide intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2026to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and children < 12 years old with an anastomotic esophageal stricture following repair of congenital esophageal atresia / tracheoesophageal fistula
- Dysphagia score ≥1
- Parental consent
Who cannot join
- Additional stricture/s besides anastomotic stricture eg. Congenital stricture
- Complicated stricture - including length >2cm, significant angulation or irregularity
- Neurological impairment or other cause of expected limitation to oral intake
- Previous anastomotic dilatations
- Complicated surgical course including need for re-operation, re-fistularization or surgical anastomotic leak
- Suspected or verified thoracic vascular anomaly affecting esophageal patency or function
- Verified co-diagnosis of eosinophilic esophagitis
- Any contraindication to EBD according to treating physician's planned treatment course
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Single-blinded, Randomized Controlled Trial of Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.
Endoscopic balloon dilatation (EBD) is a common therapeutic procedure performed for esophageal strictures. While the etiologies of esophageal strictures are numerous - including congenital strictures, caustic injuries and eosinophilic esophagitis (EoE) -anastomotic strictures following esophageal atresia and trachea-esophageal fistula repairs is reported as the most frequent cause in children.
Stricture dilatation is usually performed under direct endoscopic vision, with graduated balloon dilatation, utilizing increasing balloon diameters deployed until reaching a pre-determined, age-based, dilatation target. Balloon dilatation is repeated every 2-4 weeks until the target is reached. Success is defined as prolonged restoration of effective swallow with no dysphagia or dietary restrictions. Dilatation is repeated if clinical resolution is not obtained, or if symptoms return after initial resolution.
Read more
In children, a stricture is considered refractory when the age-appropriate esophageal lumen is not achieved with five dilatations within 5 months, or if despite ≥7 dilatations overall an age-appropriate esophageal lumen was not maintained.
Several interventions have been studied to improve the efficacy of balloon dilatation, including injecting corticosteroids at the dilatation site, topical Mitomycin C following dilatation, or pre-dilatation endoscopic incisions of the anastomotic scar tissue. All these interventions are performed endoscopically at the time of the dilatation, require advanced endoscopic skills and may potentially have associated additional risk.
In this study the investigators aim to test the efficacy and safety of topical budesonide gel following EBD for anastomotic esophageal strictures in a single-blinded, randomized controlled study of children.
Read the detailed description
This single-blinded randomized controlled trial aims to prospectively evaluate the efficacy of swallowed budesonide gel following EBD of esophageal strictures. Due to the variable nature of congenital strictures and the more disparate features of caustic and EoE strictures, the study is limited to simple strictures at the site of anastomoses.
Patients will be assessed as per the ESPGHAN and NASPGHAN guidelines for the evaluation and treatment of children with esophageal atresia-trachoesophageal fistula, with gastroscopy performed either at one-year of age or earlier in symptomatic patients with dysphagia.
Patients in whom an anastomotic esophageal stricture is identified, dilatations will be performed as per physician discretion regarding diameter and timing of dilatations, guided predominantly by the aforementioned treatment guidelines. Patients will be randomly assigned to either budesonide gel (1mg/8mL) 250mcg orally twice daily for 12 weeks from the first dilatation, or to standard of care with no oral budesonide. Treating physician will be blinded to patient treatment Esophageal stricture characteristics will be recorded at each endoscopy with pre-dilation diameter (estimated based on relative size to pre-measured biopsy forceps placed in proximity to the stricture) and maximal dilatation diameter at each session.
Patients will be assessed clinically routinely at 1, 2, 3, 4 and 6 months following initial dilatation, and at 6 months following the last dilatation in the series, during which dysphagia symptom score and patient weight will be assessed.
Success is defined as restoration of effective swallow with no dysphagia or age-appropriate dietary restrictions for 3 months. Outcome measures will include number of EBD procedures until success is achieved, as well as the rate of restenosis (defined clinically as a dysphagia score of ≥1) after success is achieved 6 months following the last EBD procedure.
The primary aim of the study is to assess the number of dilatations required to achieve clinical success between the treatment and placebo group. Secondary aims include rate of refractory strictures, restenosis rate, dysphagia score, patient weight and safety (including cortisol suppression, oral or esophageal fungal infection, and anthropomorphics).
- Conditions
- Esophageal Stricture
- Being tested
- Budesonide intervention
- Keywords
- EBD, esophageal stricture, Oral viscous budesonide
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide interventionDrug
Patients will receive budesonide gel (1mg/8mL) 250mcg orally twice daily for 12 weeks from the first dilatation.
| Study group | Role | What they receive |
|---|---|---|
| Budesonide arm | Experimental | Patients will take budesonide gel (1mg/8mL) 250mcg orally twice daily for 12 weeks from the first dilatation. Receives: Drug: Budesonide intervention |
| Control arm | No intervention | Patients will not receive any treatment following their dilations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of EBD procedures required to achieve clinical success.
The number of endoscopic balloon dilatation (EBD) procedures required to achieve clinical success (defined as effective swallowing without dysphagia or dietary restriction for 3 months) will be compared between the Budesonide and control groups.
Measured: From the first dilation up to 6 months after the initial dilation.
Secondary outcomes (6)
Restenosis rate 6 months after last EBD performed
The rate of restenosis, defined clinically as a dysphagia score ≥1, will be compared between the Budesonide and control groups. Restenosis will be assessed following confirmation of clinical success.
Measured: Up to 6 months after the last dilation.
Rate of refractory strictures
The rate of refractory strictures will be compared between the Budesonide and control groups. A stricture is considered refractory when the age-appropriate esophageal lumen is not achieved after five dilatations within 5 months, or after ≥7 dilatations in total.
Measured: Up to 5 months from the initial dilatation, or until the 7th dilatation, whichever occurs first.
Patient Weight
Weight gain trajectories will be compared between the Budesonide arm and the control arm to evaluate whether improved stricture resolution and swallowing function contribute to improved growth outcomes.
Measured: Up to 6 months after the last dilation.
Dysphagia score
Dysphagia scores (modified dysphagia score and visual analogue scale) will be recorded at all scheduled follow-up visits to assess changes in swallowing function over time. Scores will be compared between the Budesonide and control groups to evaluate whether the intervention results in reduced severity of dysphagia. The modified dysphagia score, based on the Szegedi et al. scale, ranges from 0 (no swallowing problems) to 6 (aphagia), with increasing scores reflecting greater severity of swallowing impairment, from food avoidance or occasional difficulty to difficulty with semisolids, liquids, or complete inability to swallow.
Measured: From baseline until 6 months following the last dilation.
Pre-dilatation stricture diameter at each procedure
The esophageal stricture diameter immediately prior to balloon dilation will be recorded at each EBD procedure. Serial measurements will be analyzed to compare stricture remodeling between the Budesonide and control arms, assessing whether the intervention is associated with greater pre-dilatation lumen size over time or reduced re-narrowing between procedures.
Measured: From baseline until final dilation, on average 6 months following the first.
Procedure complication rate
The rate of procedure and treatment related complications, including iatrogenic esophageal perforation, evidence of cortisol suppression, and oral or esophageal candidiasis, will be assessed to evaluate the safety of Budesonide compared with standard care. Complications will be identified during each EBD procedure and at all clinical follow-up visits.
Measured: From the first dilation through 6 months after the final dilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Pediatric Gastroenterology, Hepatology and Nutrition
- Responsible party
- Principal investigator, Oren Ledder, MD, Shaare Zedek Medical Center
- Investigators
- Oren Leder, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560462
- Sponsor's protocol ID
- Budesonide following EBD
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blinded, Randomized Controlled Trial of Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.
- ClinicalTrials.gov ID
- NCT07560462
- Acronym / sponsor ID
- Budesonide following EBD
- Conditions
- Esophageal Stricture
- Keywords
- EBD, esophageal stricture, Oral viscous budesonide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- European Society of Pediatric Gastroenterology, Hepatology and Nutrition
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 1 May 2026 (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.
Endoscopic balloon dilatation (EBD) is a common therapeutic procedure performed for esophageal strictures. While the etiologies of esophageal strictures are numerous - including congenital strictures, caustic injuries and eosinophilic esophagitis (EoE) -anastomotic strictures following esophageal atresia and trachea-esophageal fistula repairs is reported as the most frequent cause in children.
Stricture dilatation is usually performed under direct endoscopic vision, with graduated balloon dilatation, utilizing increasing balloon diameters deployed until reaching a pre-determined, age-based, dilatation target. Balloon dilatation is repeated every 2-4 weeks until the target is reached. Success is defined as prolonged restoration of effective swallow with no dysphagia or dietary restrictions. Dilatation is repeated if clinical resolution is not obtained, or if symptoms return after initial resolution.
In children, a stricture is considered refractory when the age-appropriate esophageal lumen is not achieved with five dilatations within 5 months, or if despite ≥7 dilatations overall an age-appropriate esophageal lumen was not maintained.
Several interventions have been studied to improve the efficacy of balloon dilatation, including injecting corticosteroids at the dilatation site, topical Mitomycin C following dilatation, or pre-dilatation endoscopic incisions of the anastomotic scar tissue. All these interventions are performed endoscopically at the time of the dilatation, require advanced endoscopic skills and may potentially have associated additional risk.
In this study the investigators aim to test the efficacy and safety of topical budesonide gel following EBD for anastomotic esophageal strictures in a single-blinded, randomized controlled study of children.
Detailed description
This single-blinded randomized controlled trial aims to prospectively evaluate the efficacy of swallowed budesonide gel following EBD of esophageal strictures. Due to the variable nature of congenital strictures and the more disparate features of caustic and EoE strictures, the study is limited to simple strictures at the site of anastomoses.
Patients will be assessed as per the ESPGHAN and NASPGHAN guidelines for the evaluation and treatment of children with esophageal atresia-trachoesophageal fistula, with gastroscopy performed either at one-year of age or earlier in symptomatic patients with dysphagia.
Patients in whom an anastomotic esophageal stricture is identified, dilatations will be performed as per physician discretion regarding diameter and timing of dilatations, guided predominantly by the aforementioned treatment guidelines. Patients will be randomly assigned to either budesonide gel (1mg/8mL) 250mcg orally twice daily for 12 weeks from the first dilatation, or to standard of care with no oral budesonide. Treating physician will be blinded to patient treatment Esophageal stricture characteristics will be recorded at each endoscopy with pre-dilation diameter (estimated based on relative size to pre-measured biopsy forceps placed in proximity to the stricture) and maximal dilatation diameter at each session.
Patients will be assessed clinically routinely at 1, 2, 3, 4 and 6 months following initial dilatation, and at 6 months following the last dilatation in the series, during which dysphagia symptom score and patient weight will be assessed.
Success is defined as restoration of effective swallow with no dysphagia or age-appropriate dietary restrictions for 3 months. Outcome measures will include number of EBD procedures until success is achieved, as well as the rate of restenosis (defined clinically as a dysphagia score of ≥1) after success is achieved 6 months following the last EBD procedure.
The primary aim of the study is to assess the number of dilatations required to achieve clinical success between the treatment and placebo group. Secondary aims include rate of refractory strictures, restenosis rate, dysphagia score, patient weight and safety (including cortisol suppression, oral or esophageal fungal infection, and anthropomorphics).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide arm | Experimental | Drug: Budesonide interventionPatients will take budesonide gel (1mg/8mL) 250mcg orally twice daily for 12 weeks from the first dilatation. |
| Control arm | No intervention | –Patients will not receive any treatment following their dilations. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants and children < 12 years old with an anastomotic esophageal stricture following repair of congenital esophageal atresia / tracheoesophageal fistula
- Dysphagia score ≥1
- Parental consent
Key exclusion criteria (8 listed)
- Additional stricture/s besides anastomotic stricture eg. Congenital stricture
- Complicated stricture - including length >2cm, significant angulation or irregularity
- Neurological impairment or other cause of expected limitation to oral intake
- Previous anastomotic dilatations
- Complicated surgical course including need for re-operation, re-fistularization or surgical anastomotic leak
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 |
|---|---|---|
| Budesonide interventionPatients will receive budesonide gel (1mg/8mL) 250mcg orally twice daily for 12 weeks from the first dilatation. | Drug | Budesonide arm |
Primary outcome
The number of EBD procedures required to achieve clinical success.
Time frame: From the first dilation up to 6 months after the initial dilation.
The number of endoscopic balloon dilatation (EBD) procedures required to achieve clinical success (defined as effective swallowing without dysphagia or dietary restriction for 3 months) will be compared between the Budesonide and control groups.
6 secondary outcomes
Restenosis rate 6 months after last EBD performed
Time frame: Up to 6 months after the last dilation.
Rate of refractory strictures
Time frame: Up to 5 months from the initial dilatation, or until the 7th dilatation, whichever occurs first.
Patient Weight
Time frame: Up to 6 months after the last dilation.
Dysphagia score
Time frame: From baseline until 6 months following the last dilation.
Pre-dilatation stricture diameter at each procedure
Time frame: From baseline until final dilation, on average 6 months following the first.
Procedure complication rate
Time frame: From the first dilation through 6 months after the final dilation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes
Related trials for Esophageal Stricture
Enrolling by invitation
Adipose-derived Stem Cells in Treatment of Esophageal Strictures
Esophageal Stenosis Acquired
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Prospective Evaluation of AI-ECG for SHD Detection
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
RecruitingObservational study
Abbott Cephea Mitral Valve Disease Registry
Mitral Regurgitation, Mitral Stenosis
Recruiting
Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
Dysphagia, Esophageal Stricture
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.
Oren Leder, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Budesonide intervention in people with Esophageal Stricture, run by Shaare Zedek Medical Center at 1 site in Israel.
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 8 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: opening soon, as of the sponsor's last update on 1 May 2026. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oren Ledder, Dr (+972-2-6666743, orenl@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of EBD procedures required to achieve clinical success. (time frame: From the first dilation up to 6 months after the initial dilation.). 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 1 May 2026.