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
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
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
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
