UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006044 |
|---|---|
| Receipt number | R000006701 |
| Scientific Title | The Impact of use of Energy Devices during Parenchymal Transection of the Liver: a multicenter randomized controlled trial |
| Date of disclosure of the study information | 2011/07/26 |
| Last modified on | 2015/05/11 08:42:13 |
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Basic information
Public title
The Impact of use of Energy Devices during Parenchymal Transection of the Liver: a multicenter randomized controlled trial
Acronym
EPL trial
Scientific Title
The Impact of use of Energy Devices during Parenchymal Transection of the Liver: a multicenter randomized controlled trial
Scientific Title:Acronym
EPL trial
Region
| Japan |
Condition
Condition
Liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the blood loss during parenchymal transection of the liver in making use of energy devices compared with the standard ligation method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of cases to the blood loss over 1000ml between the 2 groups
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
use of the energy device
Interventions/Control_2
no use of the energy device
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients will undergo hepatectomy without biliary reconstruction. Disease: Hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, metastatic liver cancer, benign liver tumor
2)PS:0-2
3)adequate bone marrow, liver function and renal function
4)Patients agreed with this study.
Key exclusion criteria
1)the size of tumor is less than 20mm in diameter and tumor is solitary, and located in the surface of the liver.
2)Patinets will undergo hepatectomy and other surgical procedures (excluded cholecystectomy)
3)Patients cannot understand this study.
4)Pregnancy patients
5)Doctors considered that patient was not eligible.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Gotohda |
Organization
National Cancer Center Hospital East
Division name
Hepatobiliary pancreatic surgery
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa city, Chiba
TEL
04-7133-1111
ngotohda@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Gotohda |
Organization
National Cancer Center Hospital East
Division name
Hepatobiliary pancreatic surgery
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa city, Chiba
TEL
04-7133-1111
Homepage URL
ngotohda@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
A Grant-in-Aid for cancer research from the Ministry of Health, Welfare and Labor of Japan (21-7-5)
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2012 | Year | 12 | Month | 04 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 04 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 26 | Day |
Last modified on
| 2015 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006701
| 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 |
