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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
