臨床研究等提出・公開システム

Date of registration	Feb. 08, 2021
Last modified on	Mar. 31, 2022
Trial ID	jRCT1030200352

Scientific Title	Clinical study of identification of resection area in pulmonary segmentectomy using imaging simulation and near-infrared thoracoscopy
Public Title	Clinical study of identification of resection area in pulmonary segmentectomy

Completion date	Dec. 31, 2021
Result actual enrolment	20
Baseline Characteristics	Scheduled anatomical lung segmentectomy at our institution.
Participant flow	Accumulated cases smoothly as planned and reached the target number of cases
Adverse events	none
Outcome measures	The proportion of cases successfully achieving the pathological margin of error of plus or minus 10 millimeters of the simulation margin was 90. It was possible to identify 59 of 64 intersegmental planes in total, for a success rate of 92.2. There was no significant difference between simple and complex segmentectomies.
Brief summary	The combination of preoperative three dimensional computed tomography simulation and ICGNIR was effective for securing a sufficient margin in segmentectomy.
Date of posting of results summaries	Mar. 31, 2022
Date of the first journal publication of results	Mar. 03, 2022
URL hyperlink(s) related to results and publications	https://academic.oup.com/icvts/advance-article-abstract/doi/10.1093/icvts/ivac064/6541454

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1030200352

Contact for Scientific Queries	Name	Matsuura Natsumi
	Affiliation	Japanese Red Cross Maebashi Hospital
	Address	389-1 Asakura, Maebashi City, Gunma
	Telephone	+81-27-265-3333
	E-mail	nmori1130@gmail.com
Contact for Public Queries	Name	Matsuura Natsumi
	Affiliation	Japanese Red Cross Maebashi Hospital
	Address	389-1 Asakura, Maebashi City, Gunma
	Telephone	+81-27-265-3333
	E-mail	nmori1130@gmail.com

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 08, 2021
Target sample size		20
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Scheduled anatomical lung segmentectomy at our institution. Written, informed consent must be obtained before surgery.
	Exclusion Criteria	Patients with a history of allergy to the ingredients of indocyanine green Patients with a history of iodine allergy Women who are pregnant, may be pregnant, or breastfeeding
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Primary lung cancer, Metastatic lung tumor, inflammatory lung disease
Health Condition(s) Keyword		Primary lung cancer, Metastatic lung tumor, inflammatory lung disease
Primary Outcome(s)		Whether the pathological margin from the tumor can be secured within the range of plus or minus 1.0cm of the estimated preoperative margin
Secondary Outcome(s)		Score of segmental line description (Excellent;3 fair;2 poor;1) Comparison of socres between common and uncommon segmentectomy Comparison of results for margin between common and uncommon segmentectomy

Primary Sponsor	Japanese Red Cross Maebashi Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Medical ethics committee
Address	389-1 Asakura, Maebashi City, Gunma
Telephone	+81-27-265-3333
E-Mail	nmori1130@gmail.com
Approval Status	Approval
Date of approval	Jan. 04, 2021

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Mar. 31, 2022	(this page)	Changes
2	July. 09, 2021	Detail	Changes
1	Feb. 08, 2021	Detail

List of change history