UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006044
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ngotohda@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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
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

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
URL(English) https://upload.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
Registered date File name


Contact us.