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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036764
Receipt No. R000041861
Scientific Title Evaluation of lymph flow patterns in colorectal cancers using real-time indocyanine green fluorescence imaging
Date of disclosure of the study information 2019/05/20
Last modified on 2019/05/16

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Basic information
Public title Lymph flow in colorectal cancers using real-time ICG imaging
Acronym CLFP-ICG
Scientific Title Evaluation of lymph flow patterns in colorectal cancers using real-time indocyanine green fluorescence imaging
Scientific Title:Acronym CLFP-ICG
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the appropriate area of lymph node dissection through inta-operative visualization of lymphatic flow using ICG imaging
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Positive rate of lymph node metastasis in the additional area of lymph node dissection
Key secondary outcomes Clinical safety, the number of dissected lymph nodes, the existence of unexpected lymphatic flow

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
Medicine
Interventions/Control_1 1 injection of indocyanine green(2.5mg/ml) into submucosa of colon and rectum in colorectal cancer patients
2 Expansion of lymph nodes dissection area according to the acquired information by indocyanine green visualization
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 colon cancer patients who are planed to receive colectomy with lymph node dissection
Key exclusion criteria Patients with Iodine allergy
Patient with allergy to indocyanine green
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masayoshi
Middle name
Last name Nakanishi
Organization University Hospital, Kyoto Prefectural University of Medicine
Division name Digestive Surgery
Zip code 602-8566
Address 465 Kajii-cho, Kamigyo-ku Kyoto
TEL 0752515527
Email mnakan@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Michihiro
Middle name
Last name Kudou
Organization University Hospital, Kyoto Prefectural University of Medicine
Division name Digestive Surgery
Zip code 602-8566
Address 465 Kajii-cho, Kamigyo-ku Kyoto
TEL 0752515527
Homepage URL
Email posit@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto prefectural University of Medicine
Institute
Department

Funding Source
Organization Department of Surgery,Division of Digestive Surgery
Kyoto prefectural University of Medicine
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 Kyoto Prefectural University of Medicine, Institutional Review Board,
Address 465 Kajii-cho, Kamigyo-ku Kyoto
Tel 0752515337
Email rinri@koto.kpu-m.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
2019 Year 05 Month 20 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 14 Day
Date of IRB
2019 Year 05 Month 14 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2024 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
2019 Year 05 Month 16 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041861

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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