UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031943 |
|---|---|
| Receipt number | R000036452 |
| Scientific Title | Exploratory of searching about laparoscopic para-aortic lymphadenectomy for the endometrial cancer |
| Date of disclosure of the study information | 2018/03/28 |
| Last modified on | 2018/03/27 16:14:38 |
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Basic information
Public title
Exploratory of searching about laparoscopic para-aortic lymphadenectomy for the endometrial cancer
Acronym
laparoscopic para-aortic lymphadenectomy for the endometrial cancer
Scientific Title
Exploratory of searching about laparoscopic para-aortic lymphadenectomy for the endometrial cancer
Scientific Title:Acronym
laparoscopic para-aortic lymphadenectomy for the endometrial cancer
Region
| Japan |
Condition
Condition
endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantity of operative haemorrhage
Key secondary outcomes
The desection lymph node number, lymph node metastasis rate, blood transfusion rate, intraoperative and postoperative complications, QOL, 3-year PFS, 5-year OS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
laparoscopic surgery for endometrial cancer
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
| Not applicable |
Gender
Female
Key inclusion criteria
stage IB and II patients
preoperation diagnosis of the endometrial cancer
the adaptation of the open surgery
patients are older than 20 years old
PS is 0-2
Key exclusion criteria
serious heart, cerebro-vascular disease
When aspirin or warfarin cannot discontinue the fixed period of time in patients taking a drug resulting in bleeding tendency
patients with a history of the radiation therapy to the abdomen
severe renal damage patients
severe liver damage patients
When we judge that it is inappropriate cases
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoko Kato |
Organization
Kyushu University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
3-1-1 maedashi higashiku fukuokashi fukuoka prefecture Japan
TEL
0926425395
kkato@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Kodama |
Organization
Kyushu University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
3-1-1 maedashi higashiku fukuokashi fukuoka prefecture Japan
TEL
0926425395
Homepage URL
kkeisuke@gynob.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Hospital
Department of Obstetrics and Gynecology
Organization
Division
Category of Funding Organization
Self funding
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 28 | 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
It passes without complications during the art of all three cases
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
we will give a presentation at the meeting in future
Management information
Registered date
| 2018 | Year | 03 | Month | 28 | Day |
Last modified on
| 2018 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036452
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
