NCT06626802

Steroid Versus Mitomycin-C Use in Pediatric Benign Recurrent Esophageal Stricture

Intralesional Steroid Injection Versus Topical Mitomycin-C Use in Pediatric Benign Recurrent Esophageal Stricture: A Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: King Edward Medical University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of steroid injection versus topical mitomycin-C in the treatment of pediatric benign recurrent esophageal strictures. The rationale for this study is to compare the two therapeutic options in order to measure their effectiveness, in terms of improvement of Dysphagia Severity Score (DSS).

Detailed description

After taking approval from the Institutional Review Board of the university; and taking the informed consent from parents, patients fulfilling the inclusion and exclusion criteria will be enrolled in the study. They will be then randomly allocated into two groups; group A and group B. Patients in Group A will be treated with esophageal dilation with a CRE balloon (controlled radial expansion balloon). After adequate dilation of stricture, injection Mitomycin will be applied to the narrowest portion of the stricture. Patients in Group B will be treated with esophageal dilation with a CRE balloon in the same manner. After adequate dilation of stricture, Triamcinolone injection will be injected into the narrowest portion of the stricture, using a sclerotherapy injector. Dysphagia Severity Score will be noted at start of intervention, at 2 weeks after intervention and at 6 weeks post- intervention.

Conditions

• Esophageal Stricture

Interventions

Type	Name	Description
PROCEDURE	Balloon Dilation + Topical Mitomycin	Patients with recurrent esophageal strictures in Group A will undergo endoscopy and balloon dilation with a CRE balloon, followed by injection Mitomycin applied topically at stricture site (post dilation)
PROCEDURE	Balloon Dilation + Injection Triamcinolone	Patients with recurrent esophageal strictures in Group B will undergo endoscopy and balloon dilation with a CRE balloon, followed by injection Triamcinolone, injected with a sclerotherapy injector, at stricture site (post dilation)

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2024-10-04
• Last updated: 2024-10-04

Locations

1 site across 1 country: Pakistan