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

April 7, 2008 updated by: Federal University of São Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04024-002
        • Recruiting
        • Hospital Sao Paulo
        • Contact:
        • Principal Investigator:
          • Rodrigo S Machado, PhD
        • Sub-Investigator:
          • Silvio K Ogata, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of days with improved symptom (dysphagia) after dilation session.
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Esophageal diameter
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (Estimate)

October 31, 2007

Study Record Updates

Last Update Posted (Estimate)

April 9, 2008

Last Update Submitted That Met QC Criteria

April 7, 2008

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MITOMYCIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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