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

Esophageal Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00551824
• Other study ID #: MITOMYCIN
• Status: Recruiting
• Phase: N/A
• First received: October 30, 2007
• Last updated: April 7, 2008
• Start date: October 2007
• Est. completion date: March 2009

Study information

• Verified date: October 2007
• Source: Federal University of São Paulo
• Contact: Rodrigo S Machado, PhD
• Phone: 55-11-5576-4344
• Email: rodrigo[@]gastroped.epm.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

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 clinically evaluated and the dilation program will continue on discretion of the assistant doctor. The target esophageal bore is 11 mm (or 12.8 mm if age above 5 yrs).

Mitomycin C will be applied over the esophageal mucosa in the site of stricture after dilation with a cotton pledget soaked in solution (0.4mg/ml) by three minutes. The pledget will he held over the mucosa with a biopsy forceps.

Clinical evaluation. Dysphagia will be evaluated by a structured questionnaire, using a Likert scale. The patient will answer the questionnaire daily.

Main outcome measure: Number of days with improved symptom (dysphagia) after a session.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• children with esophageal strictures

• and dysphagia

• or stricture preventing endoscope to pass over it.

Exclusion Criteria:

• congenital esophageal stricture

• stricture associated to eosinophilic esophagitis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Caustic Esophageal Stricture
• Constriction, Pathologic
• Esophageal Stenosis
• Esophageal Stricture
• Peptic Esophageal Stricture
• Post-Surgical Esophageal Stricture

Intervention

Drug:
• Mitomycin C
Esophageal dilation session with topical mitomycin applied over esophageal mucosa after dilation.

Locations

Country	Name	City	State
Brazil	Hospital São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days with improved symptom (dysphagia) after dilation session.		14 days
Secondary	Esophageal diameter		14 days