UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of anastomotic blood flow in colorectal surgery using the ICG fluorescence method
Title of the study (Brief title)	Evaluation of anastomotic blood flow in colorectal surgery using the ICG fluorescence method
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of anastomotic blood flow in colorectal surgery using the ICG fluorescence method
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Possibility of prediction by evaluation of anastomotic blood flow using the ICG fluorescence method
Key secondary outcomes	1 Evaluation of anastomotic blood flow 2 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 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Scheduled for elective surgery for a colorectal cancer 2 Age>=20 3 Written informed consent
Key exclusion criteria	1 Allergic hypersensitivity of the indocyanine green 2 Allergic hypersensitivity of the iodine
Target sample size	200

Research contact person
Name of lead principal investigator	Kenji Matsuda
Organization	Wakayama Medical University of Medicine
Division name	The Second department of Surgery
Address	811-1, Kimiidera, Wakayama, Wakayama 641-8510
TEL	074-441-0613
Email	kmatsuda@wakayama-med.ac.jp

Public contact
Name of contact person	Hiromitsu Iwamoto
Organization	Wakayama Medical University of Medicine
Division name	The Second department of Surgery
Address	811-1, Kimiidera, Wakayama, Wakayama 641-8510
TEL	074-441-0613
Homepage URL
Email	hiwa@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University of Medicine
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)

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	2016 Year 07 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 15 Day
Anticipated trial start date	2016 Year 07 Month 15 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry	2019 Year 01 Month 31 Day
Date trial data considered complete	2019 Year 01 Month 31 Day
Date analysis concluded	2019 Year 01 Month 31 Day

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

Management information
Registered date	2016 Year 06 Month 24 Day
Last modified on	2019 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026365