UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preoperative arterial embolization of hepatocellular carcinoma using DC beads; embolization and resect study
Title of the study (Brief title)	Preoperative arterial embolization of hepatocellular carcinoma using DC beads; embolization and resect study
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the embolization effect of transarterial embolization using drug eluting beads on hepatocellular carcinoma and the influence to normal liver parenchyma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the efficacy of transarterial embolization of HCC using DC beads.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	transarterial embolization
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Written informed consent is obtained by patient or legal guardians. 2) Over 20 years old. 3)Survival more than three months from a registration day can be expected. 4)HCC was suspected on CT or MRI. 5) In adaptation of hepatic resection. 6) In adaptation of hepatic arterial embolization. 7)Main organ function is kept. a. White blood-cell count under 2,500/mm3 b. Platelet count under50,000/mm3 c. Hemoglobin under7.0g/mm3 d. Creatinin over 2.0mg/dl e. Total bilirubin over 3.0mg/dl
Key exclusion criteria	1) No will of hepatic resection 2) No adaptation of hepatic resection. 3) No adaptation of hepatic arterialembolization. 4) Under 20 years old. 5) Patients have severe comorbidities as follows: a:uncontrolled malignant tumor b:sever lung complications c:sever heart failure d:sever liver disease e:sever active inflammation or infection f:poor control diabetes g:Immunocompromised state including the whole steroid therapy. h:Case having complications considered to disturb completion of thehepatic resection 6) Past history of radiation exposure to the lesion. 7) Tumor thrombus reached to main portal trunk. 8) Having bleeding tendency. 9) Anticoagulant therapy cannot be interrupted. 10) In pregnant or suspected to pregnant. 11) Judged as not suitable for this clinical study by attending doctor.
Target sample size	6

Research contact person
Name of lead principal investigator	Susumu Kanazawa
Organization	Okayama University Hospital
Division name	Radiology
Address	2-5-1 Shikatacho, Okayama city
TEL	086-235-7313
Email	hirofujiwar@gmail.com

Public contact
Name of contact person	Hiroyasu Fujiwara
Organization	Okayama University Hospital
Division name	Radiology
Address	2-5-1 Shikatacho, Okayama city
TEL	086-235-7313
Homepage URL
Email	hirofujiwar@gmail.com

Sponsor
Institute	Okayama University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Nothing
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 26 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 22 Day
Last modified on	2016 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016955