An interventional study of Esophageal dilatation with steroids injection in Pediatric Disorder, Esophageal Diseases and Esophageal Stricture, sponsored by Mohammad Daboos. Recruiting at 1 site in Egypt. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Mohammad Daboos · Not applicable, Interventional, and Treatment
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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.
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.
92 studies on the registry are indexed under Esophageal Diseases; 21 are open to participants now.
This study's planned enrollment of 21 is below the median of 50 across 66 interventional studies indexed under Esophageal Diseases.
Browse Esophageal Diseases studies →Mohammad Daboos is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric patients aged less than 14 years, with refractory benign esophageal strictures and received a dilatation therapy without triamcinolone injections
Procedure: Esophageal 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
Also known as: ISIs Endoscopic dilatation
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
Time frame: 12 months
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
Time frame: 12 months
Started Mar 2022 (actual). Primary completion is estimated for Aug 2024, 28 months after the start.
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Mohammad Daboos