Prospective study of tansarterial embolization for hepatocellular carcinoma with Lipiodol added Lecithin.

UMIN ID: UMIN000000891

Registered date:15/11/2007

Basic Information

• Health condition(s) or Problem(s) studied: hepatocellar carcinoma
• Date of first enrollment: 2007/04/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Lecithin Group:We use the emulsion which added the lecithin which is a surfactant in Lipiodol for transcatheter arterial embolization.
Non-Lecithin Group:We use the Lipiodol which didn't add the lecithin for transcatheter arterial embolization.

Outcome(s)

• Primary Outcome: curative effect,response rate,survival time, survival rate
• Secondary Outcome: adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1:The patient with the anamnesis of the drug hypersensitivity. 2:The patient with contraindication of medication(Hydrochloric acid doxorubicin, Lipiodol, Gelpert and lecithin). 3:The patient with contraindication of TAE. a.Severe liver failure b.Serum Bilirubin(T-Bil):T-Bil>3mg/dl c.Large quantities of acites. 4:The patient having the activity-related infectious disease(more than fever 38.0 degrees ). 5:The patient having the a serious complication. 6:Pregnant woman. 7: Patients who are judged inappropriate to be enrolled in this study by the doctor in charge.

Related Information

• Primary Sponsor: Women's Medical University
• Secondary Sponsor: none
• Source(s) of Monetary Support: Women's Medical University,none