Actively Recruiting
Role of Topical Steroid Injection With Refractory Benign Esophageal Stricture Endoscopic Dilatation in Children
Led by Mohammad Daboos · Updated on 2024-07-23
21
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of intralesional steroid injections along with esophageal dilatation in children with refractory benign esophageal strictures. These strictures are narrowings in the esophagus that are difficult to treat and may recur after standard dilation therapy. The study focuses on pediatric patients who have not previously received steroid injections during dilation, tracking the safety and effects of the combined treatment. The procedure involves performing an upper gastrointestinal endoscopy to reach the stricture, followed by esophageal dilatation using a wire-guided polyvinyl dilator. After dilation, a long-acting steroid called triamcinolone acetonide is injected directly into the stricture area under endoscopic guidance. The steroid is diluted and injected in four quadrants around the stricture. This intervention is done under general anesthesia with the patient positioned on their left side. Participants will be followed for 12 months to monitor several outcomes including the maximum diameter achieved by dilation, the number of dilations needed, the periodic dilation index, and a score measuring swallowing difficulty. Assessments include repeated endoscopies and symptom evaluations. This ongoing monitoring helps researchers understand the procedure's impact on esophageal narrowing and swallowing function over time.
CONDITIONS
Brief Title
Role of Topical Steroid Injection With Refractory Benign Esophageal Stricture Endoscopic Dilatation in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients aged less than 14 years
- Diagnosed with refractory benign esophageal strictures
- Have received dilatation therapy without prior triamcinolone steroid injections
You will not qualify if you...
- Failure to pass a guide wire due to pharyngeal stenosis
- Presence of tracheo-esophageal fistula
- Previous triamcinolone injections at early dilatation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up over 12 months
Participants undergo esophageal dilatation combined with topical steroid injections under general anesthesia to treat refractory benign esophageal strictures.
Initial treatment visit and periodic visits for evaluation over 12 months
Duration - Up to 12 months
Participants are monitored for up to 12 months to evaluate the treatment effect on stricture size and swallowing difficulty.
Periodic visits over 12 months
Trial Site Locations
Total: 1 location
1
Mohammad Daboos
Cairo, Select, Egypt, 115678
Actively Recruiting
Research Team
M
Mohammad Daboos
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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