Clinical trial NCT00551824: Evaluation of Topical Mitomycin C as Adjuvant Drug to Esophageal Dilation in Children
Official title: Evaluation of Topical Mitomycin C as Adjuvant Drug to Endoscopic Esophageal Dilation in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Stricture
Caustic Esophageal Stricture
Peptic Esophageal Stricture
Post-Surgical Esophageal Stricture
Keywords: esophageal stricture
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2007-10-31
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Number of days with improved symptom (dysphagia) after dilation session.
timeFrame: 14 days
Secondary outcomes:
measure: Esophageal diameter
timeFrame: 14 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital São Paulo
state: SP
Study officials:
affiliation: Disciplina de Gastroenterologia Pediátrica, UNIFESP/EPM
name: Rodrigo S Machado, PhD
role: PRINCIPAL_INVESTIGATOR
References: