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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024103
Receipt No. 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

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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
Email 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
Email yfb04322@nifty.com

Sponsor
Institute Wakayama medical university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027748

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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