UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective cohort study of evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of colon cancer
Acronym	Retrospective cohort study of evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of colon cancer
Scientific Title	Retrospective cohort study of evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of colon cancer
Scientific Title:Acronym	Retrospective cohort study of evaluating the efficacy of ICG fluorescence imaging on anastomotic leakage in laparoscopic surgery of colon cancer
Region	Japan

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

Objectives
Narrative objectives1	To retrospectively evaluate the efficacy of ICG fluorescence imaging for preventing anastomotic leakage after laparoscopic surgery for colon cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the rate of anastomotic leakage
Key secondary outcomes	perfusion time after ICG injection, rate of additional resection by ICG-FI, length of additional resection by ICG-FI, postoperative complications, intraoperative complications, re-operation rate, length of postoperative hospital stay, operation time, volume of blood loss, number of harvested lymph node, distal margin, proximal margin, 3-year local recurrence rate, 3-year relapse-free survival, 3-year overall survival

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	ING intravenous administration
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	Laparoscopic surgery for colon cancer
Key exclusion criteria	synchronous resection of other organs
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Hidenobu Middle name Last name Masui
Organization	Yokosuka kyosai hospital
Division name	Department of surgery
Zip code	238-8558
Address	1-16 Yonegahama-dori, Yokosuka-shi, Kanagawa 238-8558
TEL	046-822-2710
Email	hmsi@ykh.gr.jp

Public contact
Name of contact person	1st name Hirokazu Middle name Last name Suwa
Organization	Yokosuka kyosai hospital
Division name	Department of surgery
Zip code	238-8558
Address	1-16 Yonegahama-dori, Yokosuka-shi, Kanagawa 238-8558
TEL	046-822-2710
Homepage URL
Email	hiro0302.suwa@gmail.com

Sponsor
Institute	Yokosuka kyosai hospital
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)

IRB Contact (For public release)
Organization	Yokosuka kyosai hospital clinical research ethics committee
Address	1-16 Yonegahama-dori, Yokosuka-shi, Kanagawa 238-8558
Tel	046-822-2710
Email	syomu@ykh.gr.jp

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	2020 Year 03 Month 30 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	2019 Year 08 Month 01 Day
Date of IRB	2019 Year 08 Month 26 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2024 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 30 Day
Last modified on	2020 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045581