Esophageal Diseases, Esophageal Stricture, Pediatric Disorder
Conditions
Keywords
Esophageal stricture, Steroid injection, Esophageal dilatation
Brief 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. 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.
Interventions
PROCEDUREEsophageal dilatation with steroids injection
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
Sponsors
Mohammad Daboos
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients aged less than 14 years * with refractory benign esophageal strictures * received a dilatation therapy without triamcinolone injections
Exclusion criteria
* failure to pass a guide wire secondary to pharyngeal stenosis * tracheo-esophageal fistula * those who received triamcinolone injections at early dilatation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum dilatation size | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dysphagia score | 12 months | 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 |
Countries
Egypt
Contacts
Primary ContactMohammad Daboos
Outcome results
None listed