Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001070729
Ethics application status
Approved
Date submitted
21/09/2013
Date registered
25/09/2013
Date last updated
25/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Mitomycin C in children with long caustic esophageal strictures
Scientific title
The effect of topical Mitomycin C application on resolution of dysphagia in children with long segment caustic esophageal strictures
Secondary ID [1] 283281 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dysphagia in children with caustic esophageal stricture 290157 0
Condition category
Condition code
Oral and Gastrointestinal 290549 290549 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
topical mitomycin c is applied on the site of esophageal stricture after endoscopic dilatation.
mitomycin c is prepared to have a concentration of 0.5 mg/ml to be applied on the stricture site for 5 minutes. this application is done once for 5 min at the session of endoscopic dilatation session.
endoscopic dilatation is done using flexible endoscopy and wire guided malleable dilator, we perform a dilatation session every 2 weeks in first 3 months then monthly for the next 9 months.
endoscopic dilatation is done regularly at this scheduled sessions, and mitomycin application is done every other session . this applied for 2 to 6 times according to the response of each patient and the improvement of his dysphagia ( if he get free after 2 application, no more sessions is needed)(and if he didn't get improved , we continue to 6 application times).
Intervention code [1] 288004 0
Treatment: Drugs
Intervention code [2] 288020 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290571 0
percentage of patients that get resolved from dysphagia
(no. of patients that got resolved from dysphagia/total no of the patients x 100)

dysphagia is assessed according to dysphagia scoring system graded from 0 to 4 (where 0 represent no dysphagia, 1 = dysphagia to solids, 2 = dysphagia to semisolids, 3 = dysphagia to fluids, 4 = absolute dysphagia even to saliva)
Timepoint [1] 290571 0
1 year after last dilatation session
Secondary outcome [1] 304810 0
number of dilatation sessions needed to get free from dysphagia
Timepoint [1] 304810 0
1 year after last dilatation session

Eligibility
Key inclusion criteria
patients with long segment (> 3 cm) caustic esophageal stricture
Minimum age
1 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
short strictures (< 3 cm in length)
patients underwent previous esophageal surgery
undilatable strictures
patients known to have a hypersensitivity or contraindication for mitomycin c

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
16/01/2009
Date of last participant enrolment
Anticipated
Actual
10/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5436 0
Egypt
State/province [1] 5436 0

Funding & Sponsors
Funding source category [1] 288015 0
University
Name [1] 288015 0
Pediatric Surgery Department, Ain Shams University
Country [1] 288015 0
Egypt
Primary sponsor type
University
Name
Pediatric Surgery Department, Ain Shams University
Address
56 Ramsis st., El-Abbasia
postal code: 11566
Country
Egypt
Secondary sponsor category [1] 286736 0
Hospital
Name [1] 286736 0
El-Demerdash hospital
Address [1] 286736 0
56 Ramsis st., El-Abbasia
postal code: 11566
Country [1] 286736 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289943 0
pediatric surgery departmnet, Ain Shams University
Ethics committee address [1] 289943 0
56 Ramsis st., EL-Abbasia
postal code: 11566
Ethics committee country [1] 289943 0
Egypt
Date submitted for ethics approval [1] 289943 0
Approval date [1] 289943 0
01/01/2009
Ethics approval number [1] 289943 0

Summary
Brief summary
long caustic esophageal strictures are usually difficult to be managed and have poor response to frequent endoscopic dilatation. Therefore, esophageal replacement is eventually indicated for these children. Topical mitomycin C (MMC) application has been recently used to improve the results of endoscopic dilatation for localized esophageal strictures. Our aim is to assess the role of MMC application in management of long segment caustic esophageal strictures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43198 0
Dr Khaled Mohamed El-Asmar
Address 43198 0
14 mostafa Sdek El-Rafeay, Heliopolis
postal code: 11361
Ain Shams University hospitals
Country 43198 0
Egypt
Phone 43198 0
+2 01001222624
Fax 43198 0
Email 43198 0
[email protected]
Contact person for public queries
Name 43199 0
Dr Khaled Mohamed El-Asmar
Address 43199 0
14 mostafa Sdek El-Rafeay, Heliopolis
postal code: 11361
Ain Shams University hospitals
Country 43199 0
Egypt
Phone 43199 0
+2 01001222624
Fax 43199 0
Email 43199 0
[email protected]
Contact person for scientific queries
Name 43200 0
Dr Khaled Mohamed El-Asmar
Address 43200 0
14 mostafa Sdek El-Rafeay, Heliopolis
postal code: 11361
Ain Shams University hospitals
Country 43200 0
Egypt
Phone 43200 0
+2 01001222624
Fax 43200 0
Email 43200 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.