UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the intestinal lymph flow and blood flow using Indocyanine green(ICG)fluorescence method in a colorectal surgery
Title of the study (Brief title)	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	Takeshi Ueda
Organization	Nara Medical University
Division name	Department of Surgery
Address	840 Shijocho Kashihara,Nara,Japan
TEL	0744-22-3051
Email	takeueda@naramed-u.ac.jp

Public contact
Name of contact person	Takeshi Ueda
Organization	Nara Medical University
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 01 Month 04 Day
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

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Publication of results	Unpublished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