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

NCT06514079 | Recruiting DMC

• 1 other identifier: 00012367-24-06-002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Disorder; Esophageal Diseases; Esophageal Stricture

Keywords

Esophageal stricture; Steroid injection; Esophageal dilatation

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (1)

• dysphagia score

  12 months

Study Arms (1)

refractory benign esophageal strictures patients

EXPERIMENTAL

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

Interventions

Esophageal dilatation with steroids injection PROCEDURE

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

refractory benign esophageal strictures patients

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• failure to pass a guide wire secondary to pharyngeal stenosis
• tracheo-esophageal fistula
• those who received triamcinolone injections at early dilatation

Sponsors & Collaborators

• Mohammad Daboos: lead

Study Sites (1)

Mohammad Daboos

Cairo, Select, 115678, Egypt

RECRUITING

MeSH Terms

Conditions

Esophageal Diseases; Esophageal Stenosis

Interventions

Steroids

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mohammad Daboos

  Department of pediatric surgery, faculty of medicine , Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Daboos

CONTACT

01007578148; daboosmohammad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor at Pediatric Surgery Department, Al-Azhar University.

Model Details: Pediatric patients aged less than 14 years, with refractory benign esophageal strictures and received a dilatation therapy without triamcinolone injections were included in our study

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 23, 2024
• Study Start: March 2, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 20, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

EG (1)