UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of laparoscopic indocyanine green sentinel lynph node mapping.
Title of the study (Brief title)	The efficacy of laparoscopic indocyanine green sentinel lynph node mapping.
Region	Japan

Condition
Condition	early Cervical Cancer and Endometrial Cancer
Classification by specialty	Surgery in general Obsterics and gynecology Operative medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of laparoscopic indocyanine green sentinel lymph node mapping for early Cervical Cancer and Endometrial Cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification rate of laparoscopic indocyanine green sentinel lymph node mapping for early Cervical Cancer and Endometrial Cancer.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	ICG is injected at submucousa of uterine cervix during the operation.Sentimel lymoh nodes are identified with ICG camera system device and removed to histological investigation. After that, pelvic lymph node dissection and radical / modified radical hysterectomy is performed.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Female
Key inclusion criteria	1)Patients with early Cervical Cancer stage IA2-IB1 and who chose laparoscopic operation. 2)Endometrial Cancer stage IA and who chose laparoscopic operation. 3)Patients who is diagnosed by histrogically. 4)Patiant without enlarged lymph nodes by MRI or CT.
Key exclusion criteria	1)double cancer 2)allergy for indocyanine green or iodine 3)uncontrolled complication
Target sample size	30

Research contact person
Name of lead principal investigator	Eiji Kondo
Organization	Mie university faculty of Medicine
Division name	Department of Obstetrics and Gynecology
Address	2-174, Edobashi, Tsu city, Mie, Japan
TEL	059-232-1111
Email	eijikon@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Eiji Kondo
Organization	Mie University School of Medicine
Division name	Department of Obstetrics and Gynecology
Address	2-174, Edobashi, Tsu city, Mie, Japan
TEL	059-232-1111
Homepage URL
Email	eijikon@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Mie University School of Medicine
Institute
Department

Funding Source
Organization	Department of Obstetrics and Gynecology, Mie University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 13 Day
Anticipated trial start date	2017 Year 04 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 01 Day
Last modified on	2018 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030472