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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028953
Receipt No. R000030472
Scientific Title The efficacy of laparoscopic indocyanine green sentinel lynph node mapping.
Date of disclosure of the study information 2017/09/01
Last modified on 2018/04/27

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Basic information
Public title The efficacy of laparoscopic indocyanine green sentinel lynph node mapping.
Acronym The efficacy of laparoscopic indocyanine green sentinel lynph node mapping.
Scientific Title The efficacy of laparoscopic indocyanine green sentinel lynph node mapping.
Scientific Title:Acronym 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
1st name
Middle name
Last name Eiji Kondo
Organization Mie university faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
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
1st name
Middle name
Last name Eiji Kondo
Organization Mie University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 13 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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