Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin
Condition: Hemangioma Liver
MeSH terms: Hemangioma
Study type: Interventional
Phase: Phase 1

Summary: 
      Percutaneous sclerotherapy is currently a widely used treatment for subcutaneous low-flow
      vascular malformations. Considered as a low-flow vascular malformation, symptomatic liver
      hemangiomas could also theoretically be safely and effectively treated by percutaneous
      sclerotherapy with a mixture of Bleomycin and Lipiodol. The safety and efficacy of
      percutaneous sclerotherapy was firstly introduced by the investigator's investigators in 5
      patients in a pilot study. The aim of this study is to design and conduct a study to evaluate
      the safety and efficacy of percutaneous sclerotherapy in a larger sample size with a long
      term follow-up.
    

Detailed description: 
      Twenty-five patients with symptomatic liver hemangioma will be enrolled after an informed
      consent being obtained. Patients' symptoms related to liver mass, including the pain severity
      being measured by visual analogue scale, discomfort, early satiety, or nausea will be
      recorded. Liver function tests, coagulation tests, and complete blood count will be checked
      before the intervention. A triple phase abdominal CT scan with the administration of
      intravenous contrast medium will also be performed before the procedure. Exclusion criteria
      include hepatic or renal impairment, abdominal symptoms unrelated to a liver mass,
      uncorrectable coagulopathy, lung fibrosis, allergy to contrast media, systemic infection,
      liver abscess, and biliary obstruction.

      Patients will be sufficiently hydrated with normal saline before the procedure.
      Corticosteroid and prophylactic antibiotics will be administered before the procedure.
      Antibiotics will be continued for 3 days after the procedure.

      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.

      Any complication taking place during and within 30 days after the procedure will be recorded.
      Liver function tests, coagulation tests, and complete blood count will be repeated the day
      after the procedure, and 6 months after the procedure. Also, a triple phase abdominal CT scan
      will be repeated in 6 months, and 12 months after the intervention. The patients' symptoms
      will be asked by phone after 12 months. The changes in lesion size on CT scan and in
      patients' symptoms will be evaluated.
    

Intervention name(s): sclerotherapy arm
Intervention type(s): Procedure
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: Clinical trials with a single arm investigating the safety and efficacy of percutaneous sclerotherapy of hepatic hemangiomas with the mixture of Bleomycin and Lipiodol
Masking: None (Open Label)
Primary purpose: Treatment