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

King Edward Medical University24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Esophageal Stricture

Interventions

Balloon Dilation + Topical MitomycinPROCEDURE

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)

Balloon Dilation + Injection TriamcinolonePROCEDURE

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)

Eligibility

Sex: ALLMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Children Hospital and University of Child Health Sciences Lahore

Lahore, Punjab Province, Pakistan

Outcomes

Primary Outcomes

Effectiveness measured in terms of improvement in Dysphagia Severity Score (DSS)

Patients in both groups (group A and group B) will be followed and mean dysphagia severity score will be noted at 0, 2 and 6 weeks of intervention in both the groups. Improvement in dysphagia will be monitored via a validated Dysphagia Severity Score (DSS). It is as follows: 0 Able to eat normal diet/no dysphagia 1. Able to swallow some solid foods 2. Able to swallow only semi solid foods 3. Able to swallow liquids only 4. Unable to swallow anything/total dysphagia

Time frame: 6 weeks

Data from ClinicalTrials.gov

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