UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028953
Receipt number 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 16:42:34

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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 Obstetrics 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 or person

Institute

Department of Obstetrics and Gynecology, Mie University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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