UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032399 |
|---|---|
| Receipt number | R000036952 |
| Scientific Title | Laparoscopic para-aortic lymphadenectomy for endometrial cancer stage I, II |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2020/04/27 09:08:02 |
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Basic information
Public title
Laparoscopic para-aortic lymphadenectomy for endometrial cancer stage I, II
Acronym
LPAND
Scientific Title
Laparoscopic para-aortic lymphadenectomy for endometrial cancer stage I, II
Scientific Title:Acronym
LPAND
Region
| Japan |
Condition
Condition
Endometrial cancer stage I, II
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of laparoscopic para-aortic lymphadenectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Operative time, Intra-operative blood loss, Hospital stay, Recavery time, Perioperative complication
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Laparoscopic para-aortic lymphadenectomy
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1)type II cancer of stage IA
2)stage IB or II
3)Cases of 1) or 2) diagnosed after hysterectomy
4)Cases with good general condition
5)Cases with informed consent
Key exclusion criteria
1)Cases more than 80yearas or less than 20 years
2)Cases requiring the morceration to retrieve the specimen
3)Cases with extra-uterine involvement or lymph node metastasis
4)Cases with double cancer
5)Cases without the appropriation
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Suzuki |
Organization
St. marianna University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki
TEL
044-977-8111
nao@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Imari |
| Middle name | |
| Last name | Deura |
Organization
St. marianna University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki
TEL
044-977-8111
Homepage URL
imari@marianna-u.ac.jp
Sponsor or person
Institute
St. marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. marianna University Hospital
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
St. marianna University School of Medicine
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
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
| 2018 | Year | 05 | 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
Suspended
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 26 | Day |
Last modified on
| 2020 | 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=R000036952
