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Trial registered on ANZCTR


Registration number
ACTRN12612001021864
Ethics application status
Approved
Date submitted
19/09/2012
Date registered
21/09/2012
Date last updated
21/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a new technique for drug delivery to the esophageal wall in children with caustic esophageal stricture
Scientific title
Evaluation of the technical and clinical success of a novel endoscopic technique for Mitomycin C application in children with caustic esophageal stricture
Secondary ID [1] 281256 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
esophageal stricture 287449 0
Condition category
Condition code
Oral and Gastrointestinal 287788 287788 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
a new method for endoscopic mitomycin c application on esophageal stricture
a) the dose of mitomycin c applied; 5ml (at a concentration of 0.4 mg/ml)
b) the number of times applied; 1 to 3 times in 1 month interval " the 2nd and 3rd time will be done only if the child still symptomatic after 1st session"
c) the mode of administration; topical application to esophageal stricture using rigid endoscopy and nelaton catheter for drug application
d) the approximate duration of this procedure; 15 - 25 minutes
Intervention code [1] 285724 0
Treatment: Devices
Intervention code [2] 285738 0
Treatment: Drugs
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288009 0
technichal success of the procedure
this will be assessed by:
successful delivery of the drug to stricture site and keeping it applied on it for 5 minutes
occurance of complication e.g esophageal tear
Timepoint [1] 288009 0
immediately at the time of application
Secondary outcome [1] 299270 0
clinical success of the procedure
this will be assessed by clinical resolution of dysphagia
Timepoint [1] 299270 0
6 months after application

Eligibility
Key inclusion criteria
caustic esophageal stricture
Minimum age
1 Years
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
hypersensitivity to 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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4563 0
Egypt
State/province [1] 4563 0

Funding & Sponsors
Funding source category [1] 286028 0
University
Name [1] 286028 0
Ain Shams University
Address [1] 286028 0
El- Abbasia , Cairo , Egypt
11566
Country [1] 286028 0
Egypt
Primary sponsor type
University
Name
Ain Shams University
Address
El- Abbasia , Cairo , Egypt
11566
Country
Egypt
Secondary sponsor category [1] 284842 0
None
Name [1] 284842 0
Address [1] 284842 0
Country [1] 284842 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
we tried to innovate a new easy safe precise technique for topical mitomycin c application on caustic esophageal stricture aiming for decrease incidence of recuurance of stricture after endoscopic dilatation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34730 0
Address 34730 0
Country 34730 0
Phone 34730 0
Fax 34730 0
Email 34730 0
Contact person for public queries
Name 17977 0
Khaled El-Asmar
Address 17977 0
14 mostafa sadek el-rafeay, heliopolis, cairo
11361
Country 17977 0
Egypt
Phone 17977 0
+2 01001222624
Fax 17977 0
Email 17977 0
khaled80@hotmail.com
Contact person for scientific queries
Name 8905 0
Khaled El-Asmar
Address 8905 0
14 mostafa sadek el-rafeay, heliopolis, cairo
11361
Country 8905 0
Egypt
Phone 8905 0
+2 01001222624
Fax 8905 0
Email 8905 0
khaled80@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary