UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study investigating feasibility of preoperative hepatic arterial embolization for laparoscopic anatomical liver resection
Title of the study (Brief title)	A pilot study investigating feasibility of preoperative hepatic arterial embolization for laparoscopic anatomical liver resection
Region	Japan

Condition
Condition	Liver tumor
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigate the feasibility of preoperative arterial embolization for detecting liver segment and reducing blood loss during operation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visibility of planned resection area during operation
Key secondary outcomes	Blood loss, operating time, and postoperative complications

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	preoperative arterial 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)patients desired to receive laparoscopic liver surgery 2)Maximum tumor diameter <=5cm 3)One part liver resection 4)Liver damage class A 5)Platelet count >10^5/microL 6)Written informed concent
Key exclusion criteria	1)Contact to major hepatic vein (IVC and root of hepatic veins) 2)History of upper abdominal surgery 3)History of severe cardiac dysfunction 4)History of severe pulumonary dysfunction 5)renal dysfunction (serum Cr level >1.5mg/dL) 6)Exsistence of severe A-P, A-V, or P-V shunt
Target sample size	10

Research contact person
Name of lead principal investigator	Masaki Ueno
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama 641-8510, JAPAN
TEL	073-441-0613
Email	ma@wakayama-med.ac.jp

Public contact
Name of contact person	Masaki Ueno
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama 641-8510, JAPAN
TEL	073-441-0613
Homepage URL
Email	ma@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	No funding source
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	和歌山県立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 15 Day
Anticipated trial start date	2016 Year 09 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://insights.ovid.com/crossref?an=00129689-900000000-99411
Results	In performing laaparoscopic anatomical liver resection, preoperative TACE was performed safely without specific complications and provided significant visual information during liver segmentation.
Other related information

Management information
Registered date	2016 Year 09 Month 06 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026899