UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005640 |
|---|---|
| Receipt number | R000006656 |
| Scientific Title | An efficacy and safety of laparoscopy-assisted hepatectomy |
| Date of disclosure of the study information | 2011/05/24 |
| Last modified on | 2011/12/28 12:18:34 |
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Basic information
Public title
An efficacy and safety of laparoscopy-assisted hepatectomy
Acronym
Efficacy and safety of Laparoscopy-assisted hepatectomy
Scientific Title
An efficacy and safety of laparoscopy-assisted hepatectomy
Scientific Title:Acronym
Efficacy and safety of Laparoscopy-assisted hepatectomy
Region
| Japan |
Condition
Condition
liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate the efficacy and safety of laparoscopy-assisted hepatectomy for liver tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Severity of postoperative pain
Postoperative hospital stay
Key secondary outcomes
Operation time,
Operative blood loss
Postoperative morbidity
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
| Maneuver |
Interventions/Control_1
Method
Mobilization of the liver is done with pneumo-peritoneum. Then an10-15cm of subcostal or upper median inscision is made. Hepatic parenchymal dissection is performed by CUSA (Cavitron ultrasonic surgical aspirator)under the hepatic inflow occlusion. An coagulation of hepatic parenchyma by microwave is done before hepatic dissection for decreasing in operative blood loss.
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
Indication for this study includes liver tumors which are less than 5 cm in diameter. Bile duct resection and lymph node dissection are not necessary.
And the patients have no severe complication
Key exclusion criteria
All except key inclusion criteria.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Oba |
Organization
Shizuoka General Hospital
Division name
Hepato-biliary-pancreatic surgery
Zip code
Address
4-27-1 Kita-Ando, Aoi-ku, Shizuoka, 420-0881, Japan
TEL
08-054-247-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Oba |
Organization
Shizuoka General Hospital
Division name
Hepato-biliary-pancreatic surgery
Zip code
Address
4-27-1 Kita-Ando, Aoi-ku, Shizuoka, 420-0881, Japan
TEL
08-054-247-6111
Homepage URL
noriyuki@mars.dti.ne.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka General Hospital
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
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
地方独立行政法人静岡県立病院機構静岡県立総合病院(静岡県)
Shizuoka General Hospital（Shizuoka）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 24 | 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
| 2011 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 24 | Day |
Last modified on
| 2011 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006656
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
