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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023952
Receipt No. R000026899
Scientific Title A pilot study investigating feasibility of preoperative hepatic arterial embolization for laparoscopic anatomical liver resection
Date of disclosure of the study information 2016/09/26
Last modified on 2019/02/25

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Basic information
Public title A pilot study investigating feasibility of preoperative hepatic arterial embolization for laparoscopic anatomical liver resection
Acronym A pilot study investigating feasibility of preoperative hepatic arterial embolization for laparoscopic anatomical liver resection
Scientific Title A pilot study investigating feasibility of preoperative hepatic arterial embolization for laparoscopic anatomical liver resection
Scientific Title:Acronym 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
1st name
Middle name
Last name Masaki Ueno
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama 641-8510, JAPAN
TEL 073-441-0613
Email ma@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Ueno
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://insights.ovid.com/crossref?an=00129689-900000000-99411
Number of participants that the trial has enrolled
Results In performing laaparoscopic anatomical liver resection, preoperative TACE was performed safely without specific complications and provided significant visual information during liver segmentation.
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 06 Month 15 Day
Date of IRB
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

Other
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

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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