Evaluation of Topical Mitomycin C as Adjuvant Drug to Esophageal Dilation in Children
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Purpose
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 | Intervention |
|---|---|
|
Esophageal Stricture Caustic Esophageal Stricture Peptic Esophageal Stricture Post-Surgical Esophageal Stricture |
Drug: Mitomycin C |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation of Topical Mitomycin C as Adjuvant Drug to Endoscopic Esophageal Dilation in Children |
- Number of days with improved symptom (dysphagia) after dilation session. [ Time Frame: 14 days ]
- Esophageal diameter [ Time Frame: 14 days ]
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 6 Months to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00551824
| 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 |
| 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. | |
| Principal Investigator: | Rodrigo S Machado, PhD | Disciplina de Gastroenterologia Pediátrica, UNIFESP/EPM |
More Information
| ClinicalTrials.gov Identifier: | NCT00551824 History of Changes |
| Other Study ID Numbers: | MITOMYCIN |
| Study First Received: | October 30, 2007 |
| Last Updated: | April 7, 2008 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
esophageal stricture |
Additional relevant MeSH terms:
|
Esophageal Diseases Constriction, Pathologic Esophageal Stenosis Pathological Conditions, Anatomical Gastrointestinal Diseases Digestive System Diseases Mitomycin |
Mitomycins Alkylating Agents Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Antineoplastic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 26, 2016