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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Esophageal Stricture; Caustic Esophageal Stricture; Peptic Esophageal Stricture; Post-Surgical Esophageal Stricture	Drug: Mitomycin C	Not Applicable

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	10 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Evaluation of Topical Mitomycin C as Adjuvant Drug to Endoscopic Esophageal Dilation in Children
Study Start Date :	October 2007
Estimated Primary Completion Date :	December 2008
Estimated Study Completion Date :	March 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; 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; Esophageal dilation session with topical mitomycin applied over esophageal mucosa after dilation.
Experimental: 2; 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; Esophageal dilation session with topical mitomycin applied over esophageal mucosa after dilation.

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Esophageal diameter [ Time Frame: 14 days ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	6 Months to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Rodrigo S Machado, PhD	55-11-5576-4344	rodrigo@gastroped.epm.br
Contact: Silvio K Ogata, M.D.	55-11-5579-5834	ogatask@ajato.com

Locations

Brazil
Hospital São Paulo	Recruiting
São Paulo, SP, Brazil, 04024-002
Contact: Marcelo Gancz, M.D. 55-11-5576-4093 gastroped.endo@gmail.com
Principal Investigator: Rodrigo S Machado, PhD
Sub-Investigator: Silvio K Ogata, M.D.

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator:	Rodrigo S Machado, PhD	Disciplina de Gastroenterologia Pediátrica, UNIFESP/EPM

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00551824 History of Changes
Other Study ID Numbers:	MITOMYCIN
First Posted:	October 31, 2007
Last Update Posted:	April 9, 2008
Last Verified:	October 2007

Keywords provided by Federal University of São Paulo:

esophageal stricture

Additional relevant MeSH terms:

Constriction, Pathologic; Esophageal Stenosis; Pathological Conditions, Anatomical; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mitomycins	Mitomycin; Antibiotics, Antineoplastic; Antineoplastic Agents; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors