UMIN-CTR Clinical Trial

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
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Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
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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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