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
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
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
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
