UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030825 |
|---|---|
| Receipt number | R000035184 |
| Scientific Title | Laparoscopic paraaortic lymphadenectomy for endometrial cancer |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2023/12/14 12:02:35 |
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Basic information
Public title
Laparoscopic paraaortic lymphadenectomy for endometrial cancer
Acronym
Laparoscopic paraaortic lymphadenectomy
Scientific Title
Laparoscopic paraaortic lymphadenectomy for endometrial cancer
Scientific Title:Acronym
Laparoscopic paraaortic lymphadenectomy
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety and efficacy of laparoscopic paraaortic lymphadenectomy in patients with FIGO stage I and II, intermediate or high risk of recurrence
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Operative blood loss
Key secondary outcomes
Lymph node count, transfusion rate, operative time, perioperative complication, postoperative quality of life, disease free survival, 5 year survival rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Endometrial cancer stage I, II
Key exclusion criteria
1)Lymph node greater than or equal to 15 mm in the short axis diameter
2)Huge leiomyoma or adenomyosis
3)Severe comorbidity
4)Performance status 3, 4
5)Patients judged inappropriate for this study by the physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Sekiyama |
Organization
Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name
Obstetrics and Gynecology
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
TEL
06-6312-8831
k-sekiyama@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Sekiyama |
Organization
Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name
Obstetrics and Gynecology
Zip code
530-8480
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
TEL
06-6312-8831
Homepage URL
k-sekiyama@kitano-hp.or.jp
Sponsor or person
Institute
Tazuke Kofukai Medical Research Institute Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
Tazuke Kofukai Medical Research Institute Kitano 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
Tazuke Kofukai Medical Research Institute Kitano Hospital
Address
2-4-20 Ohgimachi, Kita-ku, Osaka
Tel
06-6312-8831
rinshou@kitano-hp.or.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 | 01 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | 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 | 01 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035184
