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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033982
Receipt No. R000038750
Scientific Title Clinical trial on the availability of tumor sites marking using indocyanine green in Laparoscopic Surgery of Colon Cancer
Date of disclosure of the study information 2018/09/01
Last modified on 2019/03/12

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Basic information
Public title Clinical trial on the availability of tumor sites marking using indocyanine green in Laparoscopic Surgery of Colon Cancer
Acronym Clinical trial on the availability of tumor sites marking using indocyanine green in Laparoscopic Surgery of Colon Cancer

Scientific Title Clinical trial on the availability of tumor sites marking using indocyanine green in Laparoscopic Surgery of Colon Cancer
Scientific Title:Acronym Clinical trial on the availability of tumor sites marking using indocyanine green in Laparoscopic Surgery of Colon Cancer

Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To Evaluate the real time identification of tumor sites and lymphatic flow using the ICG in laparoscopic colorectal cancer surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The real time identification rate of tumor site and lymphatic flow
Key secondary outcomes

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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 ICG injection into the submucosa
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 ) 20 years of age and older
2 ) Histologically diagnosed as colorectal cancer, resection is scheduled
3 ) Performance status 0 - 2
4 ) Informed consent has been obtained
Key exclusion criteria 1 )Case in which lower endoscope is difficult before surgery
2 ) Allergic hypersensitivity of the indocyanine green
3 ) Not suitable for this study judged by the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Takemasa
Organization Sapporo Medical University School of Medicine
Division name Department of Surgery, Surgical Oncology and Science
Zip code 060-8543
Address S1W16, Chuo-ku, Sapporo, Japan
TEL 0116112111
Email itakemasa@sapmed.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Okita
Organization Sapporo Medical University School of Medicine
Division name Department of Surgery, Surgical Oncology and Science
Zip code 060-8543
Address S1W16, Chuo-ku, Sapporo, Japan
TEL 0116112111
Homepage URL
Email okita@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine Department of Surgery, Surgical Oncology and Science
Institute
Department

Funding Source
Organization None
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 Sapporo medical University Institutional Review Board
Address South 1, West16, Chuo-ku, Sapporo, Japan
Tel 0116112111
Email rskk3@sapmed.ac.jp

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
2018 Year 09 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
2017 Year 08 Month 10 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 01 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038750

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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