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

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).

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.

Inclusion Criteria:

• Patients up to 16 years of age belonging to both genders
• Patients with single esophageal stricture
• Patients with benign recurrent esophageal strictures
• Patients with any etiology for esophageal stricture including; post-corrosive, congenital, post-anastomotic and eosinophilic.

Exclusion Criteria:

• Patients unfit for anesthesia and/or hemodynamic instability
• Patients with hemostatic disorder (platelets <50,000 or international normalized ratio >1.5)
• Patients who have undergone esophageal surgery in last one month
• Patients with complications such as; stricture perforation, signs of air leak or mediastinitis
• Those with hypersensitivity to Mitomycin- C
• Patients with multiple strictures