UMIN-CTR Clinical Trial

Basic information
Public title	The safety of laparoscopic ICG fluorescence imaging surgery
Acronym	The safety of laparoscopic ICG fluorescence imaging surgery
Scientific Title	The safety of laparoscopic ICG fluorescence imaging surgery
Scientific Title:Acronym	The safety of laparoscopic ICG fluorescence imaging surgery
Region	Japan

Condition
Condition	All diseases suitable for gastroenterologic surgery.
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze the safety of the ICG fluorescence imaging surgery in gastroenterologic surgery.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	The occurrence of the adverse effect of ICG
Key secondary outcomes	operative method, operative time, blood loss, postoperative comlication, others

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 Device,equipment
Interventions/Control_1	The subject of this study is almost all laparoscopic surgeries. After the administration of ICG intraoperatively, the obsevation is performed under ICG fluorescence image-navigation using an image-enhanced laparoscopy.
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) Suitable for surgery under general anesthesia. 2) Over 20 years old. 3) Having a potential demand for a detection of vessels, arteries, bile ducts, or lymphatics under the fatty layer. 4) The following operation:Thoracoscopic esophagectomy, Laparoscopic gastrectomy, Laparoscopy and endoscopy cooperative surgery, Laparoscopic enterectomy, Laparoscopic coloctomy, Laparoscopic proctectomy, Laparoscopic abdominoperineal resection, Laparoscopic colecystectomy, Laparoscopic common bile duct exploration, Laparoscopic hepatectomy, Laparoscopic derooting for liver cyst.
Key exclusion criteria	1) Having allergy for ICG. 2) Having allergy for iodic contrast medium. 3) Having allergy for various drugs. 4) Having psychological or neurological disease. 5) difficult to draw an informed consent.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Toshikatsu Middle name Last name Tsuji
Organization	Ishikawa prefectural central hospital
Division name	Department of Gastroenterological Surgery
Zip code	920-8530
Address	2-1, Kuratsukihigashi, Kanazawa, Ishiwaka 920-8530 Japan
TEL	+81-76-237-8211
Email	toshi_toshi25@yahoo.co.jp

Public contact
Name of contact person	1st name Toshikatsu Middle name Last name Tsuji
Organization	Ishikawa prefectural central hospital
Division name	Department of Gastroenterological Surgery
Zip code	920-8530
Address	2-1, Kuratsukihigashi, Kanazawa, Ishiwaka 920-8530 Japan
TEL	+81-76-237-8211
Homepage URL
Email	toshi_toshi25@yahoo.co.jp

Sponsor
Institute	Ishikawa prefectural central hospital
Institute
Department

Funding Source
Organization	Ishikawa prefectural central hospital
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	Ishikawa prefectural central hospital
Address	2-1, Kuratsukihigashi, Kanazawa, Ishiwaka 920-8530 Japan
Tel	+81-76-237-8211
Email	tmurai@ipch.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	石川県立中央病院（石川県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 14 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	Completed
Date of protocol fixation	2017 Year 03 Month 15 Day
Date of IRB	2017 Year 03 Month 30 Day
Anticipated trial start date	2017 Year 06 Month 14 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 06 Month 12 Day
Last modified on	2020 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031761