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

Not Applicable

Recruiting

• Conditions: Pediatric Disorder; Esophageal Stricture; Esophageal Diseases
• Interventions: Procedure: Esophageal dilatation with steroids injection

• Registration Number: NCT06514079
• Lead Sponsor: Mohammad Daboos

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.

Study Timeline

• Study Start: 2022-03-02
• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
refractory benign esophageal strictures patients	Esophageal dilatation with steroids injection	Pediatric patients aged less than 14 years, with refractory benign esophageal strictures and received a dilatation therapy without triamcinolone injections

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mohammad Daboos; 🇪🇬 Cairo, Select, Egypt