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IRCT20191105045343N1 IRCT 2019-12-16 Shahed University Treatment of hemangioma by embolization Treatment of giant liver hemangioma by PVA particle embolization with or without bleomycin 2020-01-21 anticipated 49 Complete https://irct.ir/trial/43536 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Giant liver hemangioma. Intervention 1: Intervention group: Patients with giant liver hemangioma are treated by embolization with PVA particles and intravenous injection of bleomycin with lipiodol. Intervention 2: Control group: Patients with giant liver hemangioma are treated by embolization with PVA particles.Intervention group. Yes - There is a plan to make this available What will be shared: Information and data can be transmitted completely transparently When: Access 6 months after the results are published To whom: Data is available to everyone Conditions: Individuals are allowed to use data and results in their articles (with the reference cited) as well as to promote community health Where to obtain: Email: mohammadrhs1373 @ Gmail.com How to obtain: First, introduce the legal or legal person and use case results to make the next correspondence Comments:
public Dr.Seyed Ali Golestanha
Shahid Mostafa Khomeini Hospital,Italia street, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1445733965 +98 21 4422 3766 mohammadrhs1373@gmail.com Shahed University scientific Dr. Mohammadreza Hosseini Siyanaki
First floor, first unit, No.7 , Gholami street, Sattarkhan street
Tehran Iran (Islamic Republic of) 1454733965 +98 21 4422 3766 Mohammadrhs1373@gmail.cim Shahed University Iran (Islamic Republic of) Patients with giant hemangioma diagnosed by the relevant specialist Patients with clinical signs of hemangioma enlargement no limit no limit Both No Patient's consent Patients with INR> 1.5 D18.0 Hemangioma Treatment - Other Treatment - Other Intervention group: Patients with giant liver hemangioma are treated by embolization with PVA particles and intravenous injection of bleomycin with lipiodol. Control group: Patients with giant liver hemangioma are treated by embolization with PVA particles.Intervention group The size of liver hemangioma lesions. Timepoint: Before, immediately after the intervention, one, three, six months after the intervention. Method of measurement: Lesion size by ultrasound, CT scan, MRI. 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. The amount of pain. Timepoint: Before, immediately after the intervention, one, three, six months after the intervention. Method of measurement: Wong-baker criteria. Shahed University Approved 2019-03-04 Shahed University Ethics Committee Shahid Mostafa Khomeini Hospital,Italia street, Keshavarz Blvd, Tehran Tehran Iran (Islamic Republic of)