臨床研究等提出・公開システム

Date of registration	Jan. 19, 2022
Last modified on	Jan. 19, 2022
Trial ID	jRCT1030210558

Scientific Title	Examination of hemodynamics of liver tumors such as hepatocellular carcinoma and hepatic parenchyma using intra-arterial contrast-enhanced ultrasonography
Public Title	Examination of hemodynamics of liver tumors such as hepatocellular carcinoma and hepatic parenchyma using intra-arterial contrast-enhanced ultrasonography

Contact for Scientific Queries	Name	Shiozawa Kazue
	Affiliation	Toho University Ohashi Medical Center
	Address	2-22-36, Ohashi Meguro-ku, Tokyo
	Telephone	+81-3-3468-1251
	E-mail	k.shio@med.toho-u.ac.jp
Contact for Public Queries	Name	Shiozawa Kazue
	Affiliation	Toho University Ohashi Medical Center
	Address	2-22-36, Ohashi Meguro-ku, Tokyo
	Telephone	+81-3-3468-1251
	E-mail	k.shio@med.toho-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 27, 2021
Target sample size		50
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Based on the Evidence-based Clinical Practice Guidelines for hepatocellular carcinoma developed by the Japan Society of Hepatology, the cases in which transarterial chemoembolization or hepatic arterial infusion chemotherapy for hepatocellular carcinoma were selected and consent was obtained for this study.
	Exclusion Criteria	Based on the same guidelines, the cases that are not indicated for transarterial chemoembolization or hepatic arterial infusion chemotherapy for hepatocellular carcinoma and for which consent cannot be obtained for this study. Excludes minors.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		hepatocellular carcinoma, liver cirrhosis
Intervention(s)		We evaluate the effectiveness of intra-arterial contrast-enhanced ultrasonography for the hemodynamics of liver tumors such as hepatocellular carcinoma and the hepatic parenchyma.
Health Condition(s) Code		D006528
Intervention(s) Code		D006528
Primary Outcome(s)		1. Recurrence rate and survival time after transarterial chemoembolization for hepatocellular carcinoma. 2. Adverse events Transarterial chemoembolization: a. Fever, b. Abdominal pain, c. Nausea, vomiting, d. Puncture bleeding, e. Renal disorder, f. Inguinal hematoma, g. Liver dysfunction, h. Liver abscess, i. Intratumoral hemorrhage Intra-arterial contrast-enhanced ultrasound: a. Diarrhea, b. Headache, c. Proteinuria, d. Neutrocytopenia, e. Rash, f. Dry mouth, g. Itching, h. Dyspnea, i. Low blood pressure

Primary Sponsor	Toho University Ohashi Medical Center

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Ethics committee of Toho University Medical Center Ohashi Hospital
Address	2-22-36, Ohashi Meguro-ku, Tokyo
Telephone	+81-3-3468-1251
E-Mail	ohashi.rinri@ext.toho-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 27, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none