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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016341
Receipt No. R000018962
Scientific Title Evaluation of run-out cancer cells during laparoscopic surgery in hepato-biliary pancreatic diseases
Date of disclosure of the study information 2015/03/01
Last modified on 2015/01/26

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Basic information
Public title Evaluation of run-out cancer cells during laparoscopic surgery in hepato-biliary pancreatic diseases
Acronym Evaluation of run-out cancer cells during laparoscopic surgery in hepato-biliary pancreatic diseases
Scientific Title Evaluation of run-out cancer cells during laparoscopic surgery in hepato-biliary pancreatic diseases
Scientific Title:Acronym Evaluation of run-out cancer cells during laparoscopic surgery in hepato-biliary pancreatic diseases
Region
Japan

Condition
Condition Hepatobliary-pancreatic diseases
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of run-out cancer cells in laparoscopic surgery compared with open surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Positivity of tumor marker expressing cells in blood and drain discharge, evaluation of cut-surface, and difference in preoperative treatment.
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Laparoscopic surgery
Interventions/Control_2 Open surgery
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

Not applicable
Gender Male and Female
Key inclusion criteria 2) PS:0-1
3)
Neutrophil >= 1,000 /mm3
Platelet >= 50,000 /mm3
Hb >= 8.0 g/dL
AST and ALT =< 400 U/L
Bilirubin =< 3.0 mg/dL
creatinin =< 2.0 mg/dL
4) written informed consent
Key exclusion criteria 1) R2 resection
2) Small remnant liver (estimated liver volume < 30%)
3) Others
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shogo Kobayashi
Organization Osaka Medical Center for Cancer and Cardiovascular diseases
Division name Surgery
Zip code
Address 1-3-3 Nakamichi Higashinari-ku Osaka
TEL 06-6972-1181
Email s-kobayashi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shogo Kobayashi
Organization Osaka Medical Center for Cancer and Cardiovascular diseases
Division name Surgery
Zip code
Address 1-3-3 Nakamichi Higashinari-ku Osaka
TEL 06-6972-1181
Homepage URL
Email s-kobayashi@umin.ac.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular diseases
Institute
Department

Funding Source
Organization Osaka Medical Center for Cancer and Cardiovascular diseases
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2015 Year 03 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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 26 Day
Last modified on
2015 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018962

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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