Objectives: Study of therapeutic outcome and complications of Percutanous sclerotherapy of symptomatic liver hemangioma with Bleomycin
Design:
Single center pilot study, 5 individuals sample size, Without blinding or randomization.
Setting and conduct:
In Patients with symptomatic liver hemangioma and with therapeutic indication undergo ultrasound guided sclerotherapy with Belomycin, Liver function tests and routine blood tests are done before the procedure and one week later. Triphasic CT-scan of liver is done 6 month after the procedure to evaluate therapeutic outcome.
(4) Participants including major eligibility criteria:
Patients with symptomatic liver hemangioma with therapeutic indication with confirmed diagnosis based on triphasic CT-scan or dynamic MRI.
(5) Intervention:
Percutanous sclerotherapy of symptomatic liver hemangioma with Bleomycin
(6) Main outcome measures:
Volume of liver hemangioma 6 month after sclerotherapy; Abdominal symptoms of patients
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021626599N1
Registration date:2016-03-31, 1395/01/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-31, 1395/01/12
Registrant information
Name
Hadi Rokni Yazdi
Name of organization / entity
Advanced Diagnostic and Interventional Radiology Research Center, Tehran University of Medical Scien
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1579
Email address
rokniyaz@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tehran University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Percutanous sclerotherapy of symptomatic liver hemangioma with Bleomycin, a pilot study
Public title
Sclerotherapy of liver hemangioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with symptomatic liver hemangioma with therapeutic indication with confirmed diagnosis based on triphasic CT-scan or dynamic MRI.
Exclusion criteria: Those patients that their abdominal complaints could be attributed to another cause, apart from liver hemangioma
Age
From 16 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd Ghods Street Central Building of TUMS 6th Floor
City
Tehran
Postal code
Approval date
2015-09-22, 1394/06/31
Ethics committee reference number
IR.TUMS.REC.1394.1377
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
Volume of lesion
Timepoint
6 month after therapy
Method of measurement
Digital volumetry
Secondary outcomes
1
Description
Abdominal pain
Timepoint
one month and 6 month after procedure
Method of measurement
visual analog scale
Intervention groups
1
Description
Intervention group:
Under local anesthectic and ultrasound guidance, needle is advanced into the liver hemangioma.Under flurouscopy contrast agent (Lipiodol) is injected to rule out communication of the lesion with portal vein or bile ducts.
Then sclerotherapy agent (bleomycin 0.5IU/kg) is injected into the hemangioma tissue. The patient is kept under superviosion for 4 hours in the ward and then is discharged
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex, Medical Imaging Center
Full name of responsible person
Hadi Rokni Yazdi
Street address
Bagherkhan Street, Imam Khomeini Hospital Complex
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Akbari
Street address
Tehran, Keshavarz blvd, Ghods Street, Tehran University of Tehran Central Bulding, 6th floor
City
Tehran
Grant name
-
Grant code / Reference number
29429-98-02-94
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Hadi Rokni Yazdi
Position
Professor-MD
Other areas of specialty/work
Street address
Tehran-Bagherkhan Street, Imam Khomeini Hospital, Medical Imaging Center
City
Tehran
Postal code
Phone
+98 21 6658 1536
Fax
Email
rokniyaz@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hadi Rokni yazdi
Position
MD
Other areas of specialty/work
Street address
Tehran-Bagherkhan Street, Imam Khomeini Hospital, Medical Imaging Center
City
Tehran
Postal code
Phone
+98 21 6658 1536
Fax
Email
rokniyaz@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Hadi Rokni Yazdi
Position
MD/ professor
Other areas of specialty/work
Street address
Tehran-Bagherkhan Street, Imam Khomeini Hospital, Medical Imaging Center
City
Tehran
Postal code
Phone
+98 21 6658 1536
Fax
Email
rokniyaz@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)