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

Not Applicable

Completed

• Conditions: Esophageal Stricture
• Interventions: Procedure: Balloon Dilation + Topical Mitomycin; Procedure: Balloon Dilation + Injection Triamcinolone

• Registration Number: NCT06626802
• Lead Sponsor: King Edward Medical University

Brief 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.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Study First Submitted: 2024-09-24
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Mitomycin	Balloon Dilation + Topical 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 B: Triamcinolone	Balloon Dilation + Injection 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.

Primary Outcome Measures

Name	Time	Method
Effectiveness measured in terms of improvement in Dysphagia Severity Score (DSS)	6 weeks	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

Trial Locations

Locations (1)

Children Hospital and University of Child Health Sciences Lahore; 🇵🇰 Lahore, Punjab, Pakistan