UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of sentinel lymph node biopsy guided by indocyanine green fluorescence imaging for colon cancer
Acronym	Sentinel node biopsy guided by indocyanine green fluorescence imaging for colon cancer
Scientific Title	Feasibility study of sentinel lymph node biopsy guided by indocyanine green fluorescence imaging for colon cancer
Scientific Title:Acronym	Sentinel node biopsy guided by indocyanine green fluorescence imaging for colon cancer
Region	Japan

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

Objectives
Narrative objectives1	To invastigate the identification rates of sentinel lymph node guided by indocyanine green fluorescence imaging
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The identification rate of sentinel lymph node
Key secondary outcomes

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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	During cololectomy, Indocyanine green is submucosally injected via endoscopy around tumor and sentinel lymph nodes are picked up using indocyanine green fluorescence imaging.
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) Histologically proven adenocarcinoma of colon or rectum adenocarcinoma. 2) solitary tumor. 3) cT2 or cT3 or cT4a or cT4b. 4) cN0. 5) D3 lymph node dissection is planned to be performed. 6) Age of 20 years or older. 7) No history of colorectomy. 8) Written informed consent.
Key exclusion criteria	1) Allergy for indocyanine green or iodine. 2) Cannot enroll to this study for any other reasons.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masaki Mori
Organization	Osaka University
Division name	Department of Gastroenterological Surgery
Zip code
Address	2-2, Yamadaoka, Suita, Osaka
TEL	+81-6-6879-3251
Email	mmori@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hidekazu Takahashi
Organization	Osaka University
Division name	Department of Gastroenterological Surgery
Zip code
Address	2-2, Yamadaoka, Suita, Osaka
TEL	+81-6-6879-3251
Homepage URL
Email	htakahashi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Osaka University
Institute
Department

Funding Source
Organization	Osaka University Graduate School of Medicine
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	2017 Year 10 Month 01 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	2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 10 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	2017 Year 09 Month 15 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033341