Patients with symptomatic liver hemangioma undergoing sclerotherapy (percutaneous injection) with 45 units of Bleomycin once during the procedure

Hemangioma Liver

The liver mass will be punctured under guidance of ultrasonography with a 20- or 22-gauge Chiba needle. Contrast medium will be injected under fluoroscopy guidance to assess any possible communication with the biliary tree and to evaluate the amount of sclerosing agent which could be safely injected. Then, the mixture of Bleomycin (Bleocin-S; Korea United Pharm Inc., South Korea) and Lipiodol (Ultra-Fluid, Guerbet, France) will be slowly injected under continuous guidance of fluoroscopy. No more than 45 units of Bleomycin and 15 cc of Lipiodol will be injected in a single session.

sclerotherapy arm

Imam Khomeini Hospital Complex, Tehran University of Medical Sciences

Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin

Pain is subjectively assessed based on a visual analog scale (VAS) before and 6 months after intervention. Change in VAS is recorded.
VAS is between zero (no pain at all) and 10 (worst pain imaginable).

Incidence of major adverse events that may cause any of the following: A) Require therapy, minor hospitalization (less than 48 hours) B) Require major therapy, unplanned increase in level of care, prolonged hospitalization (more than 48 hours) C) Permanent adverse sequel D) Death

The size of the hemangioma is assessed on CT scans performed before and 6 months after the procedure. The largest diameter of the hemangioma is measured on axial images.

Tehran University of Medical Sciences

Clinical trials with a single arm investigating the safety and efficacy of percutaneous sclerotherapy of hepatic hemangiomas with the mixture of Bleomycin and Lipiodol

For unilobar disease, two treatments will be planned, separated by four weeks. For bilobar disease, there will be four treatments planned, alternating between right and left lobe, separated by 2 weeks duration.

Colorectal Cancer Metastatic

DEBIRI

Singapore General Hospital

National Cancer Centre Singapore

Pilot Study to Assess the Safety and Pharmacokinetics of 70-150μm Drug Eluting Beads Loaded With Irinotecan (DEBIRI).

Pilot Study to Assess the Safety and Pharmacokinetics of 70-150μm Drug Eluting Beads Loaded With Irinotecan (DEBIRI) in the Treatment of Hepatic Colorectal Metastases

By looking at the number of patients with adverse events according to Health Science Authority's Safety Reporting for Clinical Trials (June 2011)

liver abscess/nudności

Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin

Pilot Study to Assess the Safety and Pharmacokinetics of 70-150μm Drug Eluting Beads Loaded With Irinotecan (DEBIRI).

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