Evaluation of Topical Mitomycin C as Adjuvant Drug to Esophageal Dilation in Children
NCT00551824 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2008-04-09
Summary
This study aims to evaluate mitomycin C as an adjunct to endoscopic treatment of esophageal strictures.
This is a crossover, controlled, clinical trial in which children with esophageal stricture will be randomized in two groups to receive either topical mitomycin or no additional treatment during standard esophageal dilation session.
Conditions
- Esophageal Stricture
- Caustic Esophageal Stricture
- Peptic Esophageal Stricture
- Post-Surgical Esophageal Stricture
Interventions
- DRUG
-
Mitomycin C
Esophageal dilation session with topical mitomycin applied over esophageal mucosa after dilation.
Sponsors & Collaborators
-
Federal University of São Paulo
lead OTHER
Principal Investigators
-
Rodrigo S Machado, PhD · Disciplina de Gastroenterologia Pediátrica, UNIFESP/EPM
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 6 Months
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-10-31
- Primary Completion
- 2008-12-31
- Completion
- 2009-03-31
Countries
- Brazil
Study Locations
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