Esophageal StrictureNCT00551824
Evaluation of Topical Mitomycin C as Adjuvant Drug to Esophageal Dilation in Children
A study testing Mitomycin C in people with Esophageal Stricture and Caustic Esophageal Stricture, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Esophageal Stricture, Caustic Esophageal Stricture, Peptic Esophageal Stricture
- What is being tested?
- Mitomycin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with esophageal strictures
- and dysphagia
- or stricture preventing endoscope to pass over it.
Who cannot join
- congenital esophageal stricture
- stricture associated to eosinophilic esophagitis
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital São Paulo
São Paulo, São Paulo, 04024-002
Marcelo Gancz, M.D., 55-11-5576-4093, gastroped.endo@gmail.com
Rodrigo S Machado, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Stricture, Caustic Esophageal Stricture, Peptic Esophageal Stricture, Post-Surgical Esophageal Stricture
- Being tested
- Mitomycin C
- Keywords
- esophageal stricture
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin CDrug
Esophageal dilation session with topical mitomycin applied over esophageal mucosa after dilation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | First dilation session with topical mitomycin applied over esophageal mucosa after dilation.
Second dilation session (after 14 days): standard dilation without topical mitomycin. Receives: Drug: Mitomycin C |
| 2 | Experimental | First dilation session: standard dilation without topical mitomycin.
Second dilation session (after 14 days) with topical mitomycin applied over esophageal mucosa after dilation. Receives: Drug: Mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with improved symptom (dysphagia) after dilation session.
Measured: 14 days
Secondary outcomes (1)
Esophageal diameter
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2008 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Rodrigo S Machado, PhD, Principal investigator, Disciplina de Gastroenterologia Pediátrica, UNIFESP/EPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551824
- Sponsor's protocol ID
- MITOMYCIN
- Status last verified
- Oct 2007
- First submitted
- 30 Oct 2007
- Last updated
- 9 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Mitomycin C as Adjuvant Drug to Endoscopic Esophageal Dilation in Children
- ClinicalTrials.gov ID
- NCT00551824
- Acronym / sponsor ID
- MITOMYCIN
- Conditions
- Esophageal Stricture, Caustic Esophageal Stricture, Peptic Esophageal Stricture, Post-Surgical Esophageal Stricture
- Keywords
- esophageal stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 31 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Mitomycin CFirst dilation session with topical mitomycin applied over esophageal mucosa after dilation. Second dilation session (after 14 days): standard dilation without topical mitomycin. |
| 2 | Experimental | Drug: Mitomycin CFirst dilation session: standard dilation without topical mitomycin. Second dilation session (after 14 days) with topical mitomycin applied over esophageal mucosa after dilation. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- children with esophageal strictures
- and dysphagia
- or stricture preventing endoscope to pass over it.
Key exclusion criteria (2 listed)
- congenital esophageal stricture
- stricture associated to eosinophilic esophagitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitomycin CEsophageal dilation session with topical mitomycin applied over esophageal mucosa after dilation. | Drug | 1, 2 |
Primary outcome
Number of days with improved symptom (dysphagia) after dilation session.
Time frame: 14 days
1 secondary outcome
Esophageal diameter
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo S Machado, PhD principal investigator
Disciplina de Gastroenterologia Pediátrica, UNIFESP/EPM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitomycin C in people with Esophageal Stricture and Caustic Esophageal Stricture, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo S Machado, PhD (55-11-5576-4344, rodrigo@gastroped.epm.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days with improved symptom (dysphagia) after dilation session. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2008.