UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000014607
Receipt number	R000016955
Scientific Title	Preoperative arterial embolization of hepatocellular carcinoma using DC beads; embolization and resect study
Date of disclosure of the study information	2014/08/27
Last modified on	2016/07/25 08:45:54

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Preoperative arterial embolization of hepatocellular carcinoma using DC beads; embolization and resect study

Acronym

Preoperative arterial embolization of hepatocellular carcinoma using DC beads; embolization and resect study

Scientific Title

Preoperative arterial embolization of hepatocellular carcinoma using DC beads; embolization and resect study

Scientific Title:Acronym

Preoperative arterial embolization of hepatocellular carcinoma using DC beads; embolization and resect study

Region

Japan

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery Radiology

Classification by malignancy

Malignancy

Genomic information

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

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

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

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

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Susumu Kanazawa

Organization

Okayama University Hospital

Division name

Radiology

Zip code

Address

2-5-1 Shikatacho, Okayama city

TEL

086-235-7313

Email

hirofujiwar@gmail.com

Public contact

Name of contact person

1st name

Middle name

Last name Hiroyasu Fujiwara

Organization

Okayama University Hospital

Division name

Radiology

Zip code

Address

2-5-1 Shikatacho, Okayama city

TEL

086-235-7313

Homepage URL

Email

hirofujiwar@gmail.com

Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name

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)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 27 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 08 Month 26 Day

Date of IRB

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

Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016955

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name