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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031504
Receipt No. R000035962
Scientific Title Indocyanine green fluorescence imaging for assessing risk factors of anastomotic leakage after colorectal cancer surgery
Date of disclosure of the study information 2018/02/27
Last modified on 2018/02/27

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Basic information
Public title Indocyanine green fluorescence imaging for assessing risk factors of anastomotic leakage after colorectal cancer surgery
Acronym ICG fluorescence imaging for assessing risk factor of anastomotic leakage of colorectal surgery
Scientific Title Indocyanine green fluorescence imaging for assessing risk factors of anastomotic leakage after colorectal cancer surgery
Scientific Title:Acronym ICG fluorescence imaging for assessing risk factor of anastomotic leakage of colorectal surgery
Region
Japan

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

Objectives
Narrative objectives1 To evaluate indocyanine green fluorescence imaging being useful as an independent factor of anastomotic leakage by multivariate analysis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Is it effective or not to assess blood flow at anastomotic site by indocyanine green fluorescent imaging?
Key secondary outcomes To evaluate predictive value of ICG fluorescent imaging, tumor factors and/or intraoperative factors as a risk factor 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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine Maneuver
Interventions/Control_1 To assess the blood flow at anastomotic site by comparing a direct vision with that under near infrared light after intravenous infusion of indocyanine green.
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 Patients who were diagnosed with left-sided or rectal cancer, and had operation with anastomosis
Key exclusion criteria Patients who underwent Hartmann's procedure

Patients with a right-sided or Transverse colon cancer

Patients who underwent combined resection of other organs
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Takiguchi
Organization Nagoya City University Graduate School of Medical Sciences
Division name Gastroenterological Surgery
Zip code
Address 1,Kawasumi,Mizuho-cho,Mizuho ward, Nagoya city,Aichi,Japan
TEL 052-853-8226
Email tyanagi@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Yanagita
Organization Nagoya City University Graduate School of Medical Sciences
Division name Gastroenterological Surgery
Zip code
Address 1,Kawasumi,Mizuho-cho,Mizuho ward, Nagoya city,Aichi,Japan
TEL 052-853-8226
Homepage URL
Email tyanagi@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Nagoya City University Graduate School of Medical Sciences
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
2018 Year 02 Month 27 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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
2018 Year 02 Month 27 Day
Last modified on
2018 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035962

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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