UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of colorectal anastomotic perfusion by intra-operative transanal ICG infrared fluorescence imaging
Title of the study (Brief title)	Evaluation of colorectal anastomotic perfusion by intra-operative transanal ICG infrared fluorescence imaging
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of assessment of colorectal anastomotic perfusion by intra-operative transanal ICG fluorescence imaging
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visibility of anastomotic perfusion
Key secondary outcomes	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	Indocyanine green 0.2mg/kg injection during 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Colorectal cancer surgery patient 2) Written informed consent
Key exclusion criteria	Allergic hypersensitivity of the indocyanine green
Target sample size	50

Research contact person
Name of lead principal investigator	Hisahiro Matsubara
Organization	Graduate school of medicine, Chiba University
Division name	Department of frontier surgery
Address	1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba
TEL	043-226-2109
Email	matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person	Hiroyuki Amagai
Organization	Graduate school of medicine, Chiba University
Division name	Department of frontier surgery
Address	1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba
TEL	043-226-2109
Homepage URL
Email	afua2633@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 10 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 28 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 15 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033770