UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015012
Receipt number R000017368
Scientific Title Randomized trial of embolic agents in balloon-occluded transcatheter arterial chemoembolization for hepatocellular carcinoma
Date of disclosure of the study information 2014/09/01
Last modified on 2020/02/19 13:21:15

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Basic information

Public title

Randomized trial of embolic agents in balloon-occluded transcatheter arterial chemoembolization for hepatocellular carcinoma

Acronym

Randomized trial of embolic agents in B-TACE for hepatocellular carcinoma

Scientific Title

Randomized trial of embolic agents in balloon-occluded transcatheter arterial chemoembolization for hepatocellular carcinoma

Scientific Title:Acronym

Randomized trial of embolic agents in B-TACE for hepatocellular carcinoma

Region

Japan


Condition

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of porous gelatin particles and microspheres in balloon-occuluded transcatheter arterial chemoembolization for hepatocellular carcinoma

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Therapeutic effect

Key secondary outcomes

Safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

B-TACE with porous gelatin particles

Interventions/Control_2

B-TACE with microspheres

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)Histologically or clinically diagnosed hepatocellular carcinoma
2)Unresectable hepatocellular carcinoma
3)No indication for radiofrequency ablation
4)Cure is impossible by radiofrequency ablation alone
5)Child-Pugh class A or B
6)Maximum tumor diameter less than or equal to 6 cm
7)No portal vein thrombosis, A-V shunt or A-P shunt
8)Adequate organ funcion
1. WBC >= 2000 /mm3
2. PLT >= 20000 /mm3
3. Hb >= 8.0 g /dl
4. Cr < 1.2 mg /dl
5. BUN <= 25 mg /dl
6. PT >= 50%
7. T-bil < 3.0 mg /dl
9)Patients who are considered to be appropriate to recieve TACE by their physicians

Key exclusion criteria

1)Previous history of TACE
2)Severe concomitant disease (excluding chronic liver disease)
3)Receiving sorafenib
4)Developed esophagogastric varices
5)History of severe allergy to platinum complex or iodine contrast material
6)Pregnant or lactating female
7)Patients who are considered to be inappropriate to participate in this study by their physicians

Target sample size

190


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukinori Imai

Organization

Saitama Medical University

Division name

Gastroenterology & Hepatology, Faculty of Medicine

Zip code


Address

38 Morohongo, Moroyama-cho, Iruma-gun, Saitama , Japan

TEL

049-276-1198

Email

imai@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukinori Imai

Organization

Saitama Medical University

Division name

Gastroenterology & Hepatology, Faculty of Medicine

Zip code


Address

38 Morohongo, Moroyama-cho, Iruma-gun, Saitama , Japan

TEL

049-276-1198

Homepage URL


Email

imai@saitama-med.ac.jp


Sponsor or person

Institute

Gastroenterology & Hepatology, Faculty of Medicine, Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

none

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

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 09 Month 01 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 09 Month 01 Day

Date of IRB

2014 Year 09 Month 08 Day

Anticipated trial start date

2014 Year 09 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 01 Day

Last modified on

2020 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017368


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name