Hemangioma Liver Clinical Trial
Official title:
Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04669314 -
Surgical Approach in Liver Hemangiomas
|
||
| Recruiting |
NCT03633747 -
Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma
|
Phase 1/Phase 2 |