臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 23, 2024
Last modified on	Oct. 23, 2024
Trial ID	jRCTs032240428

Scientific Title	Exploratory clinical trial on intraoperative intestinal blood flow assessment using ultrasound doppler technique
Public Title	Exploratory clinical trial on intraoperative intestinal blood flow assessment using ultrasound doppler technique

Contact for Scientific Queries	Name	Hirata Atsushi
	Affiliation	Chiba University Hospital
	Address	1-8-1, Inohana, Chuo-ku, Chiba, Chiba
	Telephone	+81-43-222-7171
	E-mail	a.hirata@chiba-u.jp
Contact for Public Queries	Name	Hirata Atsushi
	Affiliation	Chiba University Hospital
	Address	1-8-1, Inohana, Chuo-ku, Chiba, Chiba
	Telephone	+81-43-222-7171
	E-mail	a.hirata@chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 23, 2024
Actual date of first enrollment
Target sample size		8
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	1) Patients who are histologically proven to be col orectal cancer 2) Patients undergoing colorectal cancer surgery with gastrointestinal anastomosis 3) Patients whose age at registration is 20 years or older 4) Patients with General State Performance Status (ECOG) 0 to 2 5) Patients whose functions of the main organs are adequately maintained and judged to be safe for surgery by the doctor incharge of examination 6) Patients who have received sufficient explanations about participation in this study and have giv en written consent of their own free will with sufficient understanding.
	Exclusion Criteria	1) Patients with a history of allergy to ICG or iodine hypersensitivity 2) Pregnant, possibly pregnant, within 28 days pos tpartum, breastfeeding 3) Other patients judged inappropriate by the exa mining physicia
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		colorectal cancer
Intervention(s)		Evaluation of blood flow in the intestinal wall using ultrasound doppler technique before anastomosis during colorectal cancer surgery.
Health Condition(s) Keyword		colorectal cancer
Intervention(s) Keyword		ultrasound, dopler, ICG
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Difference in blood flow boundary between ultrasound doppler method and ICG method
Secondary Outcome(s)		<Secondary endpoints of efficacy> Reproducibility of ultrasound doppler method <Secondary endpoints of safety> Incidence of intraoperative adverse events Adverse events within 30 days after surgery Postoperative hospital stay

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Chiba University Hospital
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan, Chiba, C hiba, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	Oct. 10, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none