Trial Review

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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
Sex
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
6/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
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
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
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
[email protected]
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
[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.