Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202301748506567 Date of Approval: 31/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of early mitomycin application in pediatric corrosive ingestion
Official scientific title Early endoscopic mitomycin application in pediatric esophageal corrosive ingestion
Brief summary describing the background and objectives of the trial • The use of mitomycin C had beneficial effects specially when applied immediately after the induction of esophageal lesion. Mitomycin C decreases fibroblast collagen synthesis, inhibiting the synthesis of RNA and also suppresses cell proliferation at any stage of mitotic cycle, particularly in the late G2 phase. objective of trial is to assess the efficacy of topical application of mitomycin in decreased incidence of esophageal stricture following the corrosive ingestion
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Injury, Occupational Diseases, Poisoning,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2020
Actual trial start date 01/05/2021
Anticipated date of last follow up 01/06/2021
Actual Last follow-up date 30/10/2021
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Topical application of mitomycin over esophageal mucosa Once 0.4 mg about 10 ml During endoscopic procedure once Topical spray of mitomycin over esophageal mucosa in pediatric corrosive ingestion patient 30
Control Group Upper endoscopy Every 3 weeks 6 month Conventional endoscopic dilation of esophageal stricture 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any child age up to 18 yr Corrosive esophagitis grade 3 In early 48 hours from corrosive ingestion Unstable hemodynamic and respiratory system Impending perforation After 48 hours from corrosive ingestion Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Month(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/11/2020 Cairo university research ethical committee
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy Giza 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assess the efficacy of topical application of mitomycin over esophageal mucosa in pediatric corrosive ingestion patient in decrease the incidences of subsequent esophageal stricture 6month
Secondary Outcome Compare the cost effectiveness between mitomycin application and conventional endoscopic procedure 6month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric endoscopy center in Faculty of medicine Cairo university Egypt Kasr Alainy street Giza 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Kasr Alainy Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric endoscopy center in Faculty of medicine Cairo university Kasr Alainy Giza 11562 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayman Eskander dr.aymanemil@yahoo.com 01205551888 Kasr Alainy
City Postal code Country Position/Affiliation
Giza 11562 Egypt Professor of pediatrics
Role Name Email Phone Street address
Public Enquiries Sara Tarek sara.tarek2310@outlook.com 01205551917 Kasr Alainy
City Postal code Country Position/Affiliation
Giza 11562 Egypt Lecturer in pediatric Cairo university Egypt
Role Name Email Phone Street address
Scientific Enquiries Happy Sawires Happysawires@cu.edu.eg 01005446448 Kasr Alainy
City Postal code Country Position/Affiliation
Giza 11562 Egypt Professor in pediatric Cairo university Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Each individual participate that underlie the results reported in this article. After deidentifcation ( text . Tables. Figures and appendices Study Protocol 20 months Mitomycin corrosive ingestion pediatric
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information