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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00551824 on ClinicalTrials.gov