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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026728
Receipt No. R000030687
Scientific Title Evaluation of the intestinal lymph flow and blood flow using Indocyanine green(ICG)fluorescence method in a colorectal surgery
Date of disclosure of the study information 2017/03/29
Last modified on 2017/03/28

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Basic information
Public title Evaluation of the intestinal lymph flow and blood flow using Indocyanine green(ICG)fluorescence method in a colorectal surgery
Acronym Evaluation of the intestinal lymph flow and blood flow using Indocyanine green(ICG)fluorescence method in a colorectal surgery
Scientific Title Evaluation of the intestinal lymph flow and blood flow using Indocyanine green(ICG)fluorescence method in a colorectal surgery
Scientific Title:Acronym Evaluation of the intestinal lymph flow and blood flow using Indocyanine green(ICG)fluorescence method in a colorectal surgery
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the intestinal and mesenteric lymph flow using the ICG fluorescence method in a colorectal cancer surgery
Basic objectives2 Others
Basic objectives -Others Evaluation of the intestinal blood flow near the anastomosis using the ICG fluorescence method in a colorectal cancer surgery
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1 Identification rate of lymphatic vessels and fluorescent lymph nodes near the tumor.

2 Evaluation of blood flow of the anastomotic site
Key secondary outcomes 1 Identification rate of sentinel lymph node

2 Number of fluorescent lymph node/ number of removal lymph node

3 Incidence rate of anastomotic leakage

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 1 Indocyanine green local injection at the colorectal surgery

2 Indocyanine green intravenous injection at the colorectal surgery
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Colorectal cancer surgery patient

2 Written informed consent
Key exclusion criteria 1 Allergic hypersensitivity of the indocyanine green

2 Cases of incapacity decided by attending physicians
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Ueda
Organization Nara Medical University
Division name Department of Surgery
Zip code
Address 840 Shijocho Kashihara,Nara,Japan
TEL 0744-22-3051
Email takeueda@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Ueda
Organization Nara Medical University
Division name Department of Surgery
Zip code
Address 840 Shijocho Kashihara, Nara
TEL 0744-22-3051
Homepage URL
Email takeueda@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
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
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 奈良県立医科大学付属病院(奈良県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 29 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
2013 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 29 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
2017 Year 03 Month 28 Day
Last modified on
2017 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030687

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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