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