Study of the effect of Percutaneous embolization with bleomycin sclerosing in patients with symptomatic liver hemangiomas
Design
This study is a non-blinded clinical trial. The study population included all patients who referred to Imam Reza hospital of Kermanshah and whose liver ultrasound showed hepatic hemangioma. 19 eligible patients will be selected conveniently and randomly assigned to the intervention and control groups.
Settings and conduct
This study which will be conducted in Imam Reza hospital of Kermanshah is a non-blinded one. At the beginning of the study, the hemangioma profile in terms of the largest diameter and volume of measurement along with clinical signs are recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: A giant hepatic hemangioma with clear margins; The number of platelets is more than 100,000; International Ratio Normalized less than 1/5
Exclusion criteria: Patients with severe ascites; Improper position of the hemangioma; Patients with hepatic or renal impairment
Intervention groups
In the intervention group, sclerotherapy (with 18 or 20 gage needles) will be performed with a mixture of 20 cc of IU 45 Bleomycin in 10 cc of distilled water and 10 cc of lipividol. No intervention will be performed in the control group.
Main outcome variables
Ultrasound volume, the largest diameter of ultrasound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N154
Registration date:2020-11-06, 1399/08/16
Registration timing:prospective
Last update:2020-11-06, 1399/08/16
Update count:0
Registration date
2020-11-06, 1399/08/16
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
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
Study of the effect of Percutaneous embolization with bleomycin sclerosing in patients with symptomatic liver hemangiomas
Public title
The effect of Percutaneous embolization in patients with symptomatic liver hemangiomas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A giant hepatic hemangioma with clear margins
The number of platelets is more than 100,000
International Ratio Normalized less than 1/5
Exclusion criteria:
Patients with severe ascites
Improper position of the hemangioma
Patients with hepatic or renal impairment
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
19
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups of 19. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-03-02, 1398/12/12
Ethics committee reference number
ir.kums.rec.1399.226
Health conditions studied
1
Description of health condition studied
Liver symptomatic hemangioma
ICD-10 code
D18.0
ICD-10 code description
Haemangioma, any site
Primary outcomes
1
Description
Ultrasound volume
Timepoint
At the beginning of the study and 6 months after the end of the study
Method of measurement
Using the GE-Logic S6 ultrasound device
2
Description
Largest diameter of ultrasond
Timepoint
At the beginning of the study and 6 months after the end of the study
Method of measurement
Using the GE-Logic S6 ultrasound device
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, sclerotherapy (with 18 or 20 gage needles) will be performed with a mixture of 20 cc of IU 45 Bleomycin in 10 cc of distilled water and 10 cc of lipividol
Category
Treatment - Other
2
Description
No intervention will be performed in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Loura Khanian
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Loura.Khanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Loura Khanian
Position
Resident Radiology
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Loura.Khanian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Gharib SAlehi
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Kumssalehi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Loura Khanian
Position
Resident Radiology
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Loura.Khanian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 15-day timeframe