臨床研究等提出・公開システム

Date of registration	June. 12, 2019
Last modified on	July. 01, 2020
Trial ID	jRCTs061190006

Scientific Title	Usefulness of indocyanine green fluorescence imaging system in laparoscopic gastrointestinal cancer surgery (Usefulness of ICG in laparoscopic surgery)
Public Title	Usefulness of indocyanine green fluorescence imaging system in laparoscopic gastrointestinal cancer surgery (Usefulness of ICG in laparoscopic surgery)

Completion date	April. 30, 2020
Result actual enrolment	0
Baseline Characteristics	There was no patient.
Participant flow	No special instruction
Adverse events	No special instruction
Outcome measures	No special instruction
Brief summary	Although a research plan was made, there were no cases of the content planned during the study period, so the study was terminated.
Date of posting of results summaries	July. 01, 2020

Plan to share IPD	No
Plan description	No IPD was performed without enrolled cases.
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs061190006

Contact for Scientific Queries	Name	Watanabe Yuji
	Affiliation	Ehime University Hospital
	Address	Shitsukawa, Toon, Ehime
	Telephone	+81-899605975
	E-mail	yuji@m.ehime-u.ac.jp
Contact for Public Queries	Name	Watanabe Yuji
	Affiliation	Ehime University Hospital
	Address	Shitsukawa, Toon, Ehime
	Telephone	+81-89-960-5975
	E-mail	yuji@m.ehime-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		June. 01, 2019
Target sample size		100
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Gastrointestinal cancer patient schedule for intestinal resection with lymph node dissection in laparoscopic surgery
	Exclusion Criteria	1. Patient has allergy for ICG 2. Patient has allergy for iodine contrast medium
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		gastrointestinal cancer
Intervention(s)		ICG injection into the submucosal layer before gastrointestinal cancer surgery
Primary Outcome(s)		Visibility
Secondary Outcome(s)		Preoperative optimal timing of ICG injection, Intraluminal diffusion area of ICG, Visibility of lymph nodes

Secondary Sponsor

Name of Certified Review Board	Certified Review Board, Ehime University
Address	Shitsukawa, Toon,, Ehime
Telephone	+81-89-960-5172
E-Mail	rinri@m.ehime-u.ac.jp
Approval Status	Approval
Date of approval	April. 25, 2019

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	July. 01, 2020	(this page)	Changes
2	June. 08, 2020	Detail	Changes
1	June. 12, 2019	Detail

List of change history