This study aimed to evaluate the efficacy of the treatment of giant liver hemangioma with PVA embolization with and without bleomycin at one month, three months and six months.
Design
The control group will be treated with PVA particles for the treatment of giant liver hemangioma and the intervention group will be treated with PVA particles for the treatment of giant liver hemangioma with intravenous bleomycin injection. A randomized, double-blind, placebo-controlled clinical trial using the Cochran formula will be used to measure the minimum sample size (49), Phase 3.
Settings and conduct
Patients referred to the Shahid Mustafa Khomeini Center from 98 to 99 will be embolized with PVA particles with bleomycin and will be studied after obtaining written consent from patients with PVA particles with bleomycin.
The right femoral artery will be guided by a hydrophilic guided approach with a Sledinger technique and a pigtail F 6 tail catheter will be used to perform abdominal aortography to evaluate the tumor arteries. We will then embolize the hemangioma feeder artery with PVA. Using 500-700 mm polyvinyl alcohol particles, according to the protocol, our IU30 bleomycin (2 vials 15 IU) will be used for smaller hemangiomas 10 cm in diameter.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Patients with giant liver hemangioma have been diagnosed definitively by specialist physicians.
2. Patients with symptoms of hemangioma enlargement
Exclusion criteria:
1- Patients' dissatisfaction
Patients with INR> 1.5
Intervention groups
Control group: Treatment of patients with giant liver hemangioma by embolization with PVA particles
Intervention group: Treatment of patients with giant liver hemangioma by embolization with PVA particles with bleomycin
Main outcome variables
1- Size of liver hemangioma lesions
2. Level of liver enzymes
3. Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191105045343N1
Registration date:2019-12-16, 1398/09/25
Registration timing:prospective
Last update:2019-12-16, 1398/09/25
Update count:0
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
Mohammadreza Hosseini Siyanaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4422 3766
Email address
mohammadrhs1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of giant liver hemangioma by PVA particle embolization with or without bleomycin
Public title
Treatment of hemangioma by embolization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with giant hemangioma diagnosed by the relevant specialist
Patients with clinical signs of hemangioma enlargement
Exclusion criteria:
No Patient's consent
Patients with INR> 1.5
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
49
Randomization (investigator's opinion)
Randomized
Randomization description
Given the small sample size, the random number table will be used and a completely random starting point will be selected on the table with closed eyes
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, clinical caregivers, outcome assessors, data analysts, and safety and data monitoring committees had no information about treatment and intervention.
It should be noted that the research participants were all aware of the presence of one study
Before, immediately after the intervention, one, three, six months after the intervention
Method of measurement
Lesion size by ultrasound, CT scan, MRI
2
Description
liver enzymes
Timepoint
Before, immediately after the intervention, one, three, six months after the intervention
Method of measurement
Liver enzymes in the blood with a special kit
3
Description
The amount of pain
Timepoint
Before, immediately after the intervention, one, three, six months after the intervention
Method of measurement
Wong-baker criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with giant liver hemangioma are treated by embolization with PVA particles and intravenous injection of bleomycin with lipiodol.
Category
Treatment - Other
2
Description
Control group: Patients with giant liver hemangioma are treated by embolization with PVA particles.Intervention group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Dr.Mohammad reza Hosseini Siyanaki
Street address
Shahid Mostafa Khomeini Hospital, Italia street, Keshavarz Blvd,