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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-06-30

Brief Summary

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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).

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Detailed Description

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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

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Esophageal Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A: Mitomycin

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.

Group Type EXPERIMENTAL

Balloon Dilation + Topical Mitomycin

Intervention Type PROCEDURE

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)

Group B: Triamcinolone

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.

Group Type EXPERIMENTAL

Balloon Dilation + Injection Triamcinolone

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type 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)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No