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

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ClinicalTrials.gov Identifier: NCT00551824
Recruitment Status : Unknown
Verified October 2007 by Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : October 31, 2007
Last Update Posted : April 9, 2008
Sponsor:
Information provided by:
Federal University of São Paulo

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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551824


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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ClinicalTrials.gov Identifier: NCT00551824     History of Changes
Other Study ID Numbers: MITOMYCIN
First Posted: October 31, 2007    Key Record Dates
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