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 |
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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
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
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
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
| 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
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
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
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 |
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
