UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019172 |
|---|---|
| Receipt number | R000022099 |
| Scientific Title | Balloon assisted chemoembolization (BACE) for hepatocellular carcinoma: evaluation of safety and efficary |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2015/10/01 08:58:11 |
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Basic information
Public title
Balloon assisted chemoembolization (BACE) for hepatocellular carcinoma: evaluation of safety and efficary
Acronym
Balloon assisted chemoembolization (BACE)
Scientific Title
Balloon assisted chemoembolization (BACE) for hepatocellular carcinoma: evaluation of safety and efficary
Scientific Title:Acronym
Balloon assisted chemoembolization (BACE)
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of balloon assisted chemoembolization (BACE) for hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the safety of BACE, adverse events except for the side effects of chemoembolization are assessed according to SIR(Society of interventional radiology) standards of practice committee classification of complications by outcome.
Key secondary outcomes
The efficacy of BACE is assessed on contrast enhanced CT or MRI after 3 month according to RECICL classification.
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 |
Interventions/Control_1
In cases where a large volume of normal hepatic parenchyma is expected to be damaged by ordinary chemoembolization, a microballoon catheter is used to temporarily occlude the artery perfusing the normal hepatic parencyma and chemoembolization is performed through another microcatheter.
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)Diagnosis of hepatocellular carcinoma according to EASL guideline
2)Chemoembolization is indicated.
3)Performance status of 0-2
4)Liver function of Child-pugh A or B
5)eGFR is 30mL/min/1.73m2 or more
6)Platelet count of 50,000 microL or more
7)No previous treatment or 4 weeks after the previous treatment
8)Informed consent is obtained.
Key exclusion criteria
1)Rupture of hepatocellular carcinoma
2)History of surgical or endoscopic treatment of bile duct
3)Prominent arterioportal or arteriovenous shunts
4)Dissection or stenosis of 50% or more in the celiac trunk or hepatic artery
5)Hepatic coma or severe psychiatric disorder
6)Severe drug allergy including iodine contast allergy
7)Inadequate patients to undergo the procedure safely
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensaku Mori |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Radiology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575 Japan
TEL
0298533205
moriken@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensaku Mori |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Radiology
Zip code
Address
Faculty of Medicine, University of Tsukuba
TEL
0298533205
Homepage URL
moriken@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
faculty research funds
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ibaraki prefectural central hospital
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
University of Tsukuba Hospital and Ibaraki Prefectural Central Hospital（Ibaraki）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2015 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022099
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| Registered date | File name |
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