UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025837 |
|---|---|
| Receipt number | R000029689 |
| Scientific Title | Comparison of usability between microcatheter and micro-balloon catheter in superselective transcatheter arterial chemoembolization for hepatocellular carcinoma |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2017/06/28 11:41:28 |
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Basic information
Public title
Comparison of usability between microcatheter and micro-balloon catheter in superselective transcatheter arterial chemoembolization for hepatocellular carcinoma
Acronym
Comparison of usability between microcatheter and micro-balloon catheter in superselective TACE for HCC
Scientific Title
Comparison of usability between microcatheter and micro-balloon catheter in superselective transcatheter arterial chemoembolization for hepatocellular carcinoma
Scientific Title:Acronym
Comparison of usability between microcatheter and micro-balloon catheter in superselective TACE for HCC
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of usability between microcatheter and micro-balloon catheter in superselective transcatheter arterial chemoembolization for hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of superselective TACE
Key secondary outcomes
Distribution of Lipiodol after TACE
Accumulation of Lipiodol one week after TACE
Complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Micro-balloon catheter
Interventions/Control_2
Microcatheter
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)Patients with histologically or radiographically diagnosed HCC
2)Liver function Child-Pugh A or B
3)BCLC class A or B
4)patients over 20 years old
5)Tumor borden is within the Milan criteria.
Key exclusion criteria
1)No appearance of tumor stain on DSA or Cone beam CT
2)Sever drug allergy
3)No appearance of sub-segmental hepatic artery on DSA
4)Patients with four or more HCC
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoyuki Toyota |
Organization
National Hospital Organization, Kure Medicak Center and Chugoku Cancer Center
Division name
Department of Diagnostic Radiology
Zip code
Address
3-1 Aoyama-cho, Kure, Hiroshima
TEL
0823-22-3111
toyotan@kure-nh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Ishikawa |
Organization
National Hospital Organization, Kure Medicak Center and Chugoku Cancer Center
Division name
Department of Diagnostic Radiology
Zip code
Address
3-1 Aoyama-cho, Kure, Hiroshima
TEL
0823-22-3111
Homepage URL
ishikawam@kure-nh.go.jp
Sponsor or person
Institute
National Hospital Organization, Kure Medicak Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization, Kure Medicak Center and Chugoku Cancer Center
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
| 2017 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 13 | 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
| 2017 | Year | 01 | Month | 25 | Day |
Last modified on
| 2017 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029689
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/07/27 | (最新版) 研究計画書 (B-TACE) Ver1.３ 2017-2-12 ver2.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/07/27 | 症例報告書 2017-1-31.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
