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NCT Number: NCT06514079

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

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.

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Key information

Conditions

Pediatric Disorder Digestive System Diseases Esophageal Diseases Esophageal Stenosis Esophageal Stricture Gastrointestinal Diseases

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: ISIs Endoscopic dilatation

Primary outcomes

  1. Maximum dilatation size

    Time frame: 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 outcomes

  1. dysphagia score

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad Daboos

CONTACT

[email protected]

01007578148

Sponsors and collaborators

Lead sponsor

Mohammad Daboos

Other

Registry information

Acronym: ISIs

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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