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

NCT00551824 | Unknown

• 1 other identifier: MITOMYCIN
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Stricture; Caustic Esophageal Stricture; Peptic Esophageal Stricture; Post-Surgical Esophageal Stricture

Keywords

esophageal stricture

Outcome Measures

Primary Outcomes (1)

• Number of days with improved symptom (dysphagia) after dilation session.

  14 days

Secondary Outcomes (1)

• Esophageal diameter

  14 days

Study Arms (2)

1

EXPERIMENTAL

First dilation session with topical mitomycin applied over esophageal mucosa after dilation. Second dilation session (after 14 days): standard dilation without topical mitomycin.

Drug: Mitomycin C

2

EXPERIMENTAL

First dilation session: standard dilation without topical mitomycin. Second dilation session (after 14 days) with topical mitomycin applied over esophageal mucosa after dilation.

Drug: Mitomycin C

Interventions

Mitomycin C DRUG

Esophageal dilation session with topical mitomycin applied over esophageal mucosa after dilation.

1; 2

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children with esophageal strictures
• and dysphagia
• or stricture preventing endoscope to pass over it.

You may not qualify if:

• congenital esophageal stricture
• stricture associated to eosinophilic esophagitis

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Hospital São Paulo

São Paulo, São Paulo, 04024-002, Brazil

RECRUITING

MeSH Terms

Conditions

Esophageal Stenosis

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rodrigo S Machado, PhD

  Disciplina de Gastroenterologia Pediátrica, UNIFESP/EPM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo S Machado, PhD

CONTACT

55-11-5576-4344; rodrigo@gastroped.epm.br

Silvio K Ogata, M.D.

CONTACT

55-11-5579-5834; ogatask@ajato.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 30, 2007
• First Posted: October 31, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: April 9, 2008

Record last verified: 2007-10

Locations

BR (1)