Clinical Trial: Evaluation of Topical Mitomycin C as Adjuvant Drug to Esophageal Dilation in Children

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Evaluation of Topical Mitomycin C as Adjuvant Drug to Endoscopic Esophageal Dilation in Children

Brief 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.


Detailed Summary:

Topical mitomycin C has been used as an adjunct drug to endoscopic treatment of aero-digestive strictures. There has been some case reports and case series of this application in esophageal strictures in children, with good results. Nevertheless, it lacks a controlled clinical trial to access the efficacy of the mitomycin C in this context.

This study aims to evaluate mitomycin C as an adjunct to endoscopic treatment of esophageal strictures.

This is a crossover placebo-controlled single-blind clinical trial.

Patients: Subjects up to 18 year-old, with esophageal stricture requiring endoscopic dilation, either due to dysphagia or by stricture preventing passage of the endoscope.

Inclusion criteria:

  • peptic esophageal stricture
  • post-surgical esophageal stricture
  • caustic esophageal stricture

The patient will be randomized by one treatment group, either A or B.

  • A. during the first endoscopic procedure it will be applied of topical mitomycin C over the esophageal mucosa after dilation, then the second procedure (in two weeks) will be performed as a standard dilation, without mitomycin C.
  • B. the first procedure will be performed in a standard way, and after two weeks, in the second procedure mytomicin-C will be spread over the esophageal mucosa.

The allocation will not be informed to the patient. At the end of the study protocol, the patients will be clini
Sponsor: Federal University of São Paulo

Current Primary Outcome: Number of days with improved symptom (dysphagia) after dilation session. [ Time Frame: 14 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Esophageal diameter [ Time Frame: 14 days ]

Original Secondary Outcome: Same as current

Information By: Federal University of São Paulo

Dates:
Date Received: October 30, 2007
Date Started: October 2007
Date Completion: March 2009
Last Updated: April 7, 2008
Last Verified: October 2007