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

Mohammad Daboos21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pediatric Disorder Esophageal Diseases

Interventions

Esophageal dilatation with steroids injectionPROCEDURE

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

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