Role of Topical Steroid Injection With Refractory Benign Esophageal Stricture Endoscopic Dilatation in Children

ConditionsPediatric Disorder Esophageal Diseases Esophageal Stricture

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age2-14

SponsorMohammad Daboos

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric patients aged less than 14 years

with refractory benign esophageal strictures

received a dilatation therapy without triamcinolone injections

Disqualifiers

failure to pass a guide wire secondary to pharyngeal stenosis

tracheo-esophageal fistula

those who received triamcinolone injections at early dilatation

Trial design

Design model

Single group

Treatments tested in this trial

Esophageal dilatation with steroids injection
Procedure/Surgery
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

Treatment groups

21 Participants

are divided into 1 treatment group

Group A: refractory benign esophageal strictures patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mohammad Daboos

Lead sponsor

Al-Azhar University

Sponsor institution

Source ClinicalTrials.gov

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