Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000683831
Ethics application status
Approved
Date submitted
20/06/2012
Date registered
26/06/2012
Date last updated
26/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Topical Mitomycin C application in management of localized caustic esophageal stricture in children: A double-blinded randomized placebo-controlled trial
Scientific title
Topical Mitomycin C application in management of localized caustic esophageal stricture in pediatric age group: A double-blinded randomized placebo-controlled trial to assess number of dilatation needed by each group to achieve complete resolution of dysphagia
Secondary ID [1] 280709 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
caustic esophageal stricture 286751 0
Condition category
Condition code
Oral and Gastrointestinal 287050 287050 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
this trial aim to study the effect of topical Mitomycin C application on esophageal stricture site after dilating it endoscopically, aiming to decrease incidence of reccurrence and refibrosis.
Mitomycin C dose is prepared to use a concentration of 0.4 mg/ml then piece of gauze soaked with this solution is applied on stricture site for 5 minutes.
standard protocol is to do dilatation session every 2 weeks for 3 months then session every month for next 3 months
each session of dilatation take about 10 minutes
in the first session, dilation is done and assessment of stricture length is done
in the second dilation session, dilatation followed by Mitomycin/placebo application is done "application take 5 minutes"
in the following sessions, dilatation only is done
Intervention code [1] 285131 0
Treatment: Drugs
Comparator / control treatment
placebo (prepared by the pharmacist to have the same physical characteristics without the active ingredient and both mitomycin and placebo were applied by the same technique and for the same time"
Control group
Placebo

Outcomes
Primary outcome [1] 287387 0
the percentage of patients with complete resolution of dysphagia within 6 months of management as assessed using validated dysphagia scoring system
Timepoint [1] 287387 0
6 months after start of intervention
Secondary outcome [1] 298045 0
the number of dilatation sessions needed within the first 6 months of management (counted clinically)
Timepoint [1] 298045 0
6 months after start of intervention

Eligibility
Key inclusion criteria
All children with localized caustic esophageal stricture (< 3 cm in length as measured radiologically and confirmed by endoscopy
Minimum age
1 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
long (> 3 cm) or multiple strictures
patients underwent previous esophageal surgery
corrosive induced esophageal perforation
undilatable stricture
patients known to have a hypersensitivity or contraindication for MMC

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



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4373 0
Egypt
State/province [1] 4373 0

Funding & Sponsors
Funding source category [1] 285479 0
University
Name [1] 285479 0
Ain Shams University
Country [1] 285479 0
Egypt
Primary sponsor type
University
Name
Ain Shams University
Address
El- Demerdash hospital, El-Abbasia, Cairo
11381
Country
Egypt
Secondary sponsor category [1] 284331 0
Hospital
Name [1] 284331 0
El-Demerdash hospital
Address [1] 284331 0
El- Demerdash hospital, El-Abbasia, Cairo
11381
Country [1] 284331 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287496 0
Ain Shama Medical School, Surgery Department IRB#1
Ethics committee address [1] 287496 0
Ethics committee country [1] 287496 0
Egypt
Date submitted for ethics approval [1] 287496 0
Approval date [1] 287496 0
Ethics approval number [1] 287496 0
IRB 00006379

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34344 0
Address 34344 0
Country 34344 0
Phone 34344 0
Fax 34344 0
Email 34344 0
Contact person for public queries
Name 17591 0
Khaled El-Asmar
Address 17591 0
14 mostafa sadek el-rafeay, heliopolis, cairo, egypt
11361
Country 17591 0
Egypt
Phone 17591 0
+2 0100 1222624
Fax 17591 0
Email 17591 0
[email protected]
Contact person for scientific queries
Name 8519 0
Khaled El-Asmar
Address 8519 0
14 mostafa sadek el-rafeay, heliopolis, cairo, egypt
11361
Country 8519 0
Egypt
Phone 8519 0
+2 0100 1222624
Fax 8519 0
Email 8519 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.