UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023952 |
|---|---|
| Receipt number | 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 14:10:39 |
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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
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
ma@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026899
