To assess the effect of local Mitomycin C on outcome of caustic esophageal stricture
Design
The trial is a randomized, single-blinded, phase 3 with a control group. The calculated sample size is 40 patients (20 patients for each group). Randomization will be performed using the block method by randomiztion.com website. The allocation concealment was done using opaque, sequentially numbered and sealed envelopes.
Settings and conduct
This study is performed in the Pediatric Gastroenterology Referral Center in Akbar Pediatric Hospital, Mashhad, Iran. After obtaining informed consent, an envelop will be dedicated to each patient. Endoscopic dilatation of esophageal stricture will be performed for all patients. Then, for the patients of the intervention group, mitomycin gel is applied endoscopically to the site of mucosal rupture.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All children and adolescent below 21 years, caustic esophageal stricture based on barium swallow study or clinical examination, consent for participation by the patient or his guardian
Exclusion criteria: history of previous esophageal surgery
Intervention groups
Intervention group: Application of local mitomycin gel(from KOREA UNITED PHARM INC.) by endoscopy at the site of mucosal rupture, with a volume of 5 cc and a dose of 0.4 mg per cc, 5 times during the study with an interval of at least two weeks.
Control group: Patients in the control group do not receive this medication after dilatation.
Main outcome variables
Dysphagia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201116049399N1
Registration date:2020-12-31, 1399/10/11
Registration timing:registered_while_recruiting
Last update:2020-12-31, 1399/10/11
Update count:0
Registration date
2020-12-31, 1399/10/11
Registrant information
Name
Fatemeh Basirinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3605 7487
Email address
basirinezhadf971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-30, 1399/09/10
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of local Mitomycin C jelly on esophageal stricture caused by caustic ingestion
Public title
Effect of local Mitomycin C in caustic esophageal stricture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under 21-year-old
Caustic ingestion
Esophageal stricture based on barium swallow study or clinical examination
Informed consent of patients or his guardian
Exclusion criteria:
Previous esophageal surgery
Age
To 21 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
To generate a random sequence, the block method will be applied using random block size of 4 through the website www.randomization.com. Then the produced sequence will be located in sealed opaque envelopes and finally numbered by the methodologist sequentially.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyser is blinded to the group allocation. The groups are coded using A and B letters.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Ghoresishi Building, Daneshgah street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-11-15, 1399/08/25
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.466
Health conditions studied
1
Description of health condition studied
Caustic esophageal stricture
ICD-10 code
T28.1
ICD-10 code description
Burn of esophagus
Primary outcomes
1
Description
Dysphagia
Timepoint
Every two weeks after starting the study
Method of measurement
Clinical grading
2
Description
Number of Dilatation
Timepoint
Every two weeks after starting the study
Method of measurement
The number of performed procedure
Secondary outcomes
1
Description
Weight
Timepoint
every two weeks after starting the study
Method of measurement
ADE pediatric scale with 1 gram acuity
Intervention groups
1
Description
Intervention group: Patients who receive topical Mitomycin after endoscopic dilatation of caustic esophageal stricture.For patients in this group, esophageal dilatation with Savarry Gillard dilatators or through the scope (TTS) balloons will be done. after esophageal dilatation, 5 cc of mitomycin C at a concentration of 0.4 mg per cc(from KOREA UNITED FARM INC.) is applied topically through endoscopy at the site of mucosal rupture. The number of endoscopy and dilatation sessions is five times at intervals of at least two weeks.
Category
Treatment - Drugs
2
Description
Control group:Patients in the control group, like patients in the intervention group, undergo endoscopy and endoscopic esophageal dilatation at intervals of at least two weeks for five sessions, but they will not receive topical mitomycin after esophageal dilatation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar's Pediatric Hospital
Full name of responsible person
Fatemeh Basirinezhad
Street address
Akbar hospital,Shahid Kaveh 14 Alley, Shahid Kaveh Blvd. Mashhahd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3805
Email
basirinezhadf971@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Qoreishi biulding, Daneshgah Ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
981304
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Basirinezhad
Position
Sub-specialty Assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 258, Seyyed Razi 12 Alley, Seyyed Razi Ave., Vakil Abad Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9188845857
Phone
+98 51 3605 7487
Email
basirinezhadf971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Kianifar
Position
full professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric gastroenterology and Liver disease
Street address
Negin building, between Golriz and Khayam Ave., Sajjad Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9186694789
Phone
+98 51 3767 9440
Fax
Email
kianifarhr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Basirinejad
Position
Subspecialty assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.258 , Seyyed Razi 12 Allie , Seyyed Razi Ave. , Vakil Abad Blvd. , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9188845857
Phone
+98 51 3605 7487
Fax
Email
basirinezhadf971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available