UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024103 |
|---|---|
| Receipt number | R000027748 |
| Scientific Title | Clinical efficacy and safety of percutaneous transhepatic portal embolization (PTPE) with N-butyl 2-cyanoacrylate-lipiodol-ethanol (NLE) before liver resection |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2019/03/19 10:17:58 |
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Basic information
Public title
Clinical efficacy and safety of percutaneous transhepatic portal embolization (PTPE) with N-butyl 2-cyanoacrylate-lipiodol-ethanol (NLE) before liver resection
Acronym
Clinical efficacy and safety of PTPE with NLE
Scientific Title
Clinical efficacy and safety of percutaneous transhepatic portal embolization (PTPE) with N-butyl 2-cyanoacrylate-lipiodol-ethanol (NLE) before liver resection
Scientific Title:Acronym
Clinical efficacy and safety of PTPE with NLE
Region
| Japan |
Condition
Condition
hepatocellular carcinoma,intrahepatic cholangiocarcinoma,metastatic liver tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of efficacy and safety of PTPE with NLE before liver resection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedure-related complications
Key secondary outcomes
Adverse event,increase rate of residual liver volume ,changes in liver function before and after the PTPE, the portal vein recanalization
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
Perform PTPE with NLE before 3-4 weeks for right hepatic lobe resection.
NLE injection volume is determine to measure the portal vein branch of the volume of the right hepatic lobe in advance.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) case of right hepatic resection of residual liver volume less than 40%
2) 20 years of age or older and less than 80 years of age, gender is unquestioned
3) Performance status; 0,1,2
4) child-pugh grade ; A
5) Bone marrow and renal function is maintained in the preoperative clinical examination within two weeks
WBC: more than 3,000/mm3, less than 12,000/mm3
Plt: more than 70,000/mm3
Hb: more than 10.0g/dL
Cr: less than 1.5mg/dL
Key exclusion criteria
1) Ascites
2) Patients with a bleeding tendency(Plt: less than 50,000/mm3, PT-INR: more than 1.5)
3) poor renal function(eGFR: less than 30 ml/min/1.73m2)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Ikoma |
Organization
Wakayama medical university
Division name
Department of Radiology
Zip code
Address
Wakayamashi Kimiderra 811-1
TEL
073-441-0605
yfb04322@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Ikoma |
Organization
Wakayama medical university
Division name
Department of Radiology
Zip code
Address
Wakayamashi Kimiderra 811-1
TEL
073-441-0605
Homepage URL
yfb04322@nifty.com
Sponsor or person
Institute
Wakayama 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
| 2016 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027748
