UMIN-CTR Clinical Trial

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
Last 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
1st 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