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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004268
Receipt No. R000005119
Scientific Title Feasibility study of laparoscopic liver resection in National Cancer Center Hospital
Date of disclosure of the study information 2010/10/01
Last modified on 2013/09/29

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Basic information
Public title Feasibility study of laparoscopic liver resection in National Cancer Center Hospital
Acronym Feasibility study of laparoscopic liver resection in NCCH
Scientific Title Feasibility study of laparoscopic liver resection in National Cancer Center Hospital
Scientific Title:Acronym Feasibility study of laparoscopic liver resection in NCCH
Region
Japan

Condition
Condition Liver tumor or gall bladder tumor
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the feasibility of laparoscopic liver resection in the National Cancer Center Hospital
Basic objectives2 Others
Basic objectives -Others Feasibility Study
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes moderate complication rate, severe complication rate
Key secondary outcomes unexpected conversion rate

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 Laparoscopic liver resection
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
15 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Liver tumor (primary or metastatic), or gall bladder tumor confined within the muscularis propria without need for lymph node dissection or extrahepatic bile duct resection.
2) fulfilling the liver resection indication
3) ECOG Performance status (PS) 0 or 1
4) ASA (American Society of Anesthesiologists) score 2 or less
5) Major organ function is preserved
a) Alb more than 2.8g/dl
b) Plt more than 80,000/mm3
c) Hb more than 9.0g/dl
d) T-Bil less than 2.0mg/dl
e) GOT less than 200IU/L
f) GPT less than 200IU/L
g) ICG15R less than 40%
h) Cre less than 2.0mg/dl
6) Signed informed consent
Key exclusion criteria Past history of surgery causing severe intraabdominal adhesion
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Nara
Organization National Cancer Center Hospital
Division name Hepatobiliary Pancreatic Surgery Division
Zip code
Address 5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL 03-3542-2511
Email sanara@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Nara
Organization National Cancer Center Hospital
Division name Hepatobiliary Pancreatic Surgery Division
Zip code
Address 5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email sanara@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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 国立がん研究センター中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 01 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
2010 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2012 Year 10 Month 06 Day
Date of closure to data entry
2012 Year 10 Month 31 Day
Date trial data considered complete
2012 Year 10 Month 31 Day
Date analysis concluded
2012 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 09 Month 27 Day
Last modified on
2013 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005119

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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