UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004268
Receipt number 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 18:16:23

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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 or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



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

Value
https://center6.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