Topical Mitomycin C application in management of localized caustic esophageal stricture in children: A double-blinded randomized placebo-controlled trial

Phase 2

Completed

• Conditions: caustic esophageal stricture; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612000683831
• Lead Sponsor: Ain Shams University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

All children with localized caustic esophageal stricture (< 3 cm in length as measured radiologically and confirmed by endoscopy

Exclusion Criteria

long (> 3 cm) or multiple strictures
patients underwent previous esophageal surgery
corrosive induced esophageal perforation
undilatable stricture
patients known to have a hypersensitivity or contraindication for MMC

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the percentage of patients with complete resolution of dysphagia within 6 months of management as assessed using validated dysphagia scoring system[6 months after start of intervention]

Secondary Outcome Measures

Name	Time	Method
the number of dilatation sessions needed within the first 6 months of management (counted clinically)[6 months after start of intervention]