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

Mohammad Daboos

Status: Enrolling

Conditions: Esophageal Stricture; Pediatric Disorder; Esophageal Diseases

Treatments: Procedure: Esophageal dilatation with steroids injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06514079

00012367-24-06-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

refractory benign esophageal strictures patients

Experimental group

Description:

Pediatric patients aged less than 14 years, with refractory benign esophageal strictures and received a dilatation therapy without triamcinolone injections

Treatment:

Procedure: Esophageal dilatation with steroids injection