臨床研究等提出・公開システム

Japanese

Date of registration	June. 27, 2024
Last modified on	Nov. 14, 2024
Trial ID	jRCTs031240188

Scientific Title	Clinical research on analysis of pelvic lymph flow in prostate cancer, and establishment of sentinel lymph node search method for pelvic lymph node dissection navigation by ICG fluorescence method using a surgical support robot (Da Vinci Xi): a phase II exploratory clinical study
Public Title	Localization of lymph nodes by fluorescent agents in robotic prostate cancer surgery

Contact for Scientific Queries	Name	Sakamoto Shinichi
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture,
	Telephone	+81-43-226-2134
	E-mail	rbatbat1@chiba-u.jp
Contact for Public Queries	Name	Sakamoto Shinichi
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture,
	Telephone	+81-43-226-2134
	E-mail	rbatbat1@chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 27, 2024
Actual date of first enrollment
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	screening
Key inclusion & exclusion criteria	Inclusion Criteria	1)Patients with prostate cancer of stage T1-3N0-1M0 who need radical prostatectomy using da Vinci Xi. 2) Age from 35 to 85 years old. 3) PS0-1 (ECOG performance status score) 4) The examination results within three months indicate that the patient can undergo general anesthesia surgery. 5) Obtain written informed consent.
	Exclusion Criteria	1) case of iodine hypersensitivity or a history of drug allergy to a drug to be used (ICG etc.) 2) cases suspected of disseminated disease outside the pelvis 3) cases deemed inappropriate by research responsibility or research sharing physician
	Age Minimum	35age old over
	Age Maximum	85age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Prostate cancer
Intervention(s)		ICG injection during robotic surgery.
Health Condition(s) Keyword		Prostate; Cancer; Lymph node; Indicating ICG under robotic surgery
Intervention(s) Keyword		ICG; Robotsurgery; Da Vinci Xi
Health Condition(s) Code		D011471
Intervention(s) Code		D065287
Primary Outcome(s)		The percentage of pelvic lymphatic pathway (pathway A/B/C etc.) (%)
Secondary Outcome(s)		1) site-specific lymph node ICG staining 2) evaluation of the accuracy of identification of metastatic lymph nodes by ICG Sensitivity of metastatic lymph nodes The specificity of metastatic lymph nodes False-positive rate of metastatic lymph nodes False-negative rate of metastatic lymph nodes 3) safety evaluation items Number of adverse events (specific adverse events, number of responses and proportion)

Primary 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
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	June. 17, 2024

Plan to share IPD	No
Plan description	none

Secondary ID(s)	なし
Issuing Authority	N/A

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Nov. 14, 2024	(this page)	Changes
1	June. 27, 2024	Detail

List of change history