Pediatric DisorderISIsNCT06514079
Role of Topical Steroid Injection With Refractory Benign Esophageal Stricture Endoscopic Dilatation in Children
A study testing Esophageal dilatation with steroids injection in people with Pediatric Disorder and Esophageal Diseases, run by Mohammad Daboos at 1 site in Egypt.
Trial summary
This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Pediatric Disorder, Esophageal Diseases, Esophageal Stricture
- What is being tested?
- Esophageal dilatation with steroids injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2022to 20 Aug 2024
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged less than 14 years
- with refractory benign esophageal strictures
- received a dilatation therapy without triamcinolone injections
Who cannot join
- failure to pass a guide wire secondary to pharyngeal stenosis
- tracheo-esophageal fistula
- those who received triamcinolone injections at early dilatation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohammad Daboos
Cairo, Select, 115678
Mohammad Daboos, 01007578148, daboosmohammad@gmail.com
daboosmohammad@gmail.com
About this study
This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.
Read the detailed description
Background and study aims: Benign esophageal strictures are primarily treated with dilation therapy, but strictures can recur or can be unresponsive, requiring additional or repeated treatment. This study investigates the efficacy and safety of intralesional steroid injections (ISIs) in addition to dilation in patients with refractory benign esophageal strictures.
Methods: This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.
- Being tested
- Esophageal dilatation with steroids injection
- Keywords
- Esophageal stricture, Steroid injection, Esophageal dilatation
- Medical subject headings
- Esophageal Diseases, Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal dilatation with steroids injectionProcedure or surgery
Also called ISIs Endoscopic dilatation
Under general anesthesia with the patient in the left lateral position. A single-channel endoscope was used. Endoscopic bougie dilatation was performed using Wire-guided Polyvinyl dilator Savary Gilliard/SG. Long-acting steroids triamcinolone acetonide was injected via 25-gauge sclerotherapy catheter. One mL solution of triamcinolone acetonide 40mg/ml was diluted with one mL of saline, in a 2 mL disposable syringe, and 0.5 mL each was injected at the proximal margin of the stricture in four quadrants, 2 mL solution in four quadrants
| Study group | Role | What they receive |
|---|---|---|
| refractory benign esophageal strictures patients | Experimental | Pediatric patients aged less than 14 years, with refractory benign esophageal strictures and received a dilatation therapy without triamcinolone injections Receives: Procedure: Esophageal dilatation with steroids injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum dilatation size
achieving a diameter of 11 mm for patients aged <2 years, 12 mm for patients aged between 2 and 5 years, and 15 mm for children aged >5 years with complete relief of symptoms without requiring endoscopic procedure or surgical intervention for at least 6 months
Measured: 12 months
Secondary outcomes (1)
dysphagia score
Dysphagia was graded into the following:
- Score 0 - No dysphagia: able to eat a normal diet.
- Score 1 - Moderate passage: able to eat some solid foods.
- Score 2 - Poor passage: able to eat only semi-solid foods.
- Score 3 - Very poor passage: able to swallow only liquids only.
- Score 4 - No passage: unable to swallow anything
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start2 Mar 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pediatric patients aged less than 14 years, with refractory benign esophageal strictures and received a dilatation therapy without triamcinolone injections were included in our study
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammad Daboos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad Daboos, Al-Azhar University
- Investigators
- Mohammad Daboos, Principal investigator, Department of pediatric surgery, faculty of medicine , Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514079
- Sponsor's protocol ID
- 00012367-24-06-002
- Acronym
- ISIs
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Topical Steroid Injection With Refractory Benign Esophageal Stricture Endoscopic Dilatation in Children
- ClinicalTrials.gov ID
- NCT06514079
- Acronym / sponsor ID
- ISIs / 00012367-24-06-002
- Keywords
- Esophageal stricture, Steroid injection, Esophageal dilatation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Mohammad DaboosUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 23 Jul 2024 (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 clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.
Detailed description
Background and study aims: Benign esophageal strictures are primarily treated with dilation therapy, but strictures can recur or can be unresponsive, requiring additional or repeated treatment. This study investigates the efficacy and safety of intralesional steroid injections (ISIs) in addition to dilation in patients with refractory benign esophageal strictures.
Methods: This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pediatric patients aged less than 14 years, with refractory benign esophageal strictures and received a dilatation therapy without triamcinolone injections were included in our study
| Arm | Type | Receives |
|---|---|---|
| refractory benign esophageal strictures patients | Experimental | Procedure: Esophageal dilatation with steroids injectionPediatric patients aged less than 14 years, with refractory benign esophageal strictures and received a dilatation therapy without triamcinolone injections |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients aged less than 14 years
- with refractory benign esophageal strictures
- received a dilatation therapy without triamcinolone injections
Key exclusion criteria (3 listed)
- failure to pass a guide wire secondary to pharyngeal stenosis
- tracheo-esophageal fistula
- those who received triamcinolone injections at early dilatation
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 |
|---|---|---|
| Esophageal dilatation with steroids injectionAlso: ISIs Endoscopic dilatationUnder general anesthesia with the patient in the left lateral position. A single-channel endoscope was used. Endoscopic bougie dilatation was performed using Wire-guided Polyvinyl dilator Savary Gilliard/SG. Long-acting steroids triamcinolone acetonide was injected via 25-gauge sclerotherapy catheter. One mL solution of triamcinolone acetonide 40mg/ml was diluted with one mL of saline, in a 2 mL disposable syringe, and 0.5 mL each was injected at the proximal margin of the stricture in four quadrants, 2 mL solution in four quadrants | Procedure or surgery | refractory benign esophageal strictures patients |
Primary outcome
Maximum dilatation size
Time frame: 12 months
achieving a diameter of 11 mm for patients aged <2 years, 12 mm for patients aged between 2 and 5 years, and 15 mm for children aged >5 years with complete relief of symptoms without requiring endoscopic procedure or surgical intervention for at least 6 months
1 secondary outcome
dysphagia score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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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.
Mohammad Daboos principal investigator
Department of pediatric surgery, faculty of medicine , Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal dilatation with steroids injection in people with Pediatric Disorder and Esophageal Diseases, run by Mohammad Daboos at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Jul 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Daboos (01007578148, daboosmohammad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum dilatation size (time frame: 12 months). 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 Jul 2024.