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

King Edward Medical University

Status: Completed

Conditions: Esophageal Stricture

Treatments: Procedure: Balloon Dilation + Injection Triamcinolone; Procedure: Balloon Dilation + Topical Mitomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT06626802

PedEsoStricture

Details and patient eligibility

About

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).

Full 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.

Enrollment: 24 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Group A: Mitomycin

Experimental group

Description:

Patients in Group A will be treated with esophageal dilation with a CRE balloon. After adequate dilation of stricture, injection Mitomycin will be applied to the narrowest portion of the stricture. It will be applied in a dose of 1ml (0.4mg/ml); after dividing in to four aliquots, each aliquot will be applied to to one of the four quadrants.

Treatment:

Procedure: Balloon Dilation + Topical Mitomycin

Group B: Triamcinolone

Experimental group

Description:

Patients in Group B will be treated with esophageal dilation with a CRE balloon. After adequate dilation of stricture, Triamcinolone injection will be injected into the narrowest portion of the stricture, using a sclerotherapy injector. Injection triamcinolone will be used in a dose of 1ml (40mg/ml). It will be divided in to four aliquots; each aliquot will be injected in to each of the four quadrants.

Treatment:

Procedure: Balloon Dilation + Injection Triamcinolone