臨床研究等提出・公開システム

Scientific Title	Intraoperative near-infrared fluorescence imaging using indocyanine green during staging laparoscopy for detecting small metastasis in pancreatic cancer: A prospective study (NIRPC)
Public Title	NIR fluorescence imaging during staging laparoscopy for detecting metastases in pancreatic cancer (NIRPC)

Contact for Scientific Queries	Name	Fukumoto Takumi
	Affiliation	Kobe University Hospital
	Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo
	Telephone	+81-78-382-6302
	E-mail	fukumoto@med.kobe-u.ac.jp
Contact for Public Queries	Name	Nakamura Hiroyuki
	Affiliation	Kobe University Hospital
	Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo
	Telephone	+81-78-382-6302
	E-mail	zacnakamura@outlook.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 30, 2018
Actual date of first enrollment		Oct. 15, 2018
Target sample size		40
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Aged 20 or over and can provide written voluntary consent to participate - Pathologically or clinically diagnosed as pancreatic cancer - Radiographically non-metastatic disease - Planned for the staging laparoscopy followed by a local treatment: pancreatic resection or radiation
	Exclusion Criteria	- Allergy to iodine - For any reason, the investigators think that the patient should not participate
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pancreatic cancer
Intervention(s)		Indocyanine green will administer to patients intravenously before the staging laparoscopy and we will look inside the abdominal cavity with near-infrared light.
Health Condition(s) Keyword		Pancreatic cancer, Staging laparoscopy
Intervention(s) Keyword		Indocyanine green, Near-infrared light
Health Condition(s) Code		C535836
Intervention(s) Code		D007208
Primary Outcome(s)		The number of detected liver metastasis
Secondary Outcome(s)		- The rate of patients with the need to change treatment as a result of the exploration with NIR imaging - The rate of patients with allergy for ICG - The incidence of postoperative complications

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kobe University Clinical Research Ethical Comittee
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo
Telephone	+81-78-382-6669
E-Mail	cerb@med.kobe-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 13, 2019

Plan to share IPD	No
Plan description

Secondary ID(s)	UMIN000025900
Issuing Authority	UMIN Clinical Trial Registry (UMIN-CTR)

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history