UMIN-CTR Clinical Trial

Basic information
Public title	Surgical procedure using intraoperative navigation with ICG (indocyanine green) in gastrointestinal cancer
Acronym	Surgical procedure using intraoperative navigation with ICG (indocyanine green) in gastrointestinal cancer
Scientific Title	Surgical procedure using intraoperative navigation with ICG (indocyanine green) in gastrointestinal cancer
Scientific Title:Acronym	Surgical procedure using intraoperative navigation with ICG (indocyanine green) in gastrointestinal cancer
Region	Japan

Condition
Condition	Esophageal cancer, gastric cancer, duodenal cancer, Biliary tract cancer, pancreatic cancer, colon cancer
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish a surgical technique incorporating the ICG fluorescence method in gastrointestinal cancer surgery to improve the surgical results and prognosis of gastrointestinal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of fluorescence images useful for determining the extent of excision
Key secondary outcomes	Percentage of fluorescent images of lymphatic flow from the serosa of the organ to the base of the artery along the area of the dominant artery Negative margin rate in resected specimens Long-term results (relapse-free survival, overall survival)

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	Medicine
Interventions/Control_1	Submucosal and subserosal injections of the ICG gastrointestinal tract
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	Gastrointestinal cancer patients (esophageal cancer, gastric cancer, duodenal cancer, biliary tract cancer, pancreatic cancer, and colorectal cancer) surgery undergoing elective surgery at our university
Key exclusion criteria	Patients with a history of hypersensitivity to ICG components
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Sang-Woong Middle name Last name Lee
Organization	Osaka Medical and Pharmaceutical University
Division name	Department of General and Gastroenterological Surgery
Zip code	569-8686
Address	2-7 Daigaku-machi, Takatsuki city, Osaka, Japan
TEL	072-683-1221
Email	sang-woong.lee@ompu.ac.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Tanaka
Organization	Osaka Medical and Pharmaceutical University
Division name	Department of General and Gastroenterological Surgery
Zip code	569-8686
Address	2-7 Daigaku-machi, Takatsuki city, Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	ryo.tanaka@ompu.ac.jp

Sponsor
Institute	Osaka Medical and Pharmaceutical University, Department of General and Gastroenterological Surgery
Institute
Department

Funding Source
Organization	Osaka Medical and Pharmaceutical University, Department of General and Gastroenterological Surgery
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka Medical and Pharmaceutical University
Address	2-7 Daigaku-machi, Takatsuki city, Osaka, Japan
Tel	072-6883-1221
Email	rinri@ompu.ac.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	2022 Year 06 Month 03 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	Enrolling by invitation
Date of protocol fixation	2018 Year 04 Month 30 Day
Date of IRB	2019 Year 05 Month 13 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2022 Year 07 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	2022 Year 06 Month 02 Day
Last modified on	2022 Year 06 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054642