UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014813 |
|---|---|
| Receipt number | R000017221 |
| Scientific Title | a study to evaluate the efficacy of laparoscopic partial adrenalectomy in patients with adrenal tumor |
| Date of disclosure of the study information | 2014/08/11 |
| Last modified on | 2021/10/11 18:35:42 |
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Basic information
Public title
a study to evaluate the efficacy of laparoscopic partial adrenalectomy in patients with adrenal tumor
Acronym
a study to evaluate the efficacy of laparoscopic partial adrenalectomy in patients with adrenal tumor
Scientific Title
a study to evaluate the efficacy of laparoscopic partial adrenalectomy in patients with adrenal tumor
Scientific Title:Acronym
a study to evaluate the efficacy of laparoscopic partial adrenalectomy in patients with adrenal tumor
Region
| Japan |
Condition
Condition
adrenal tumor
Classification by specialty
| Endocrinology and Metabolism | Endocrine surgery | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacy of laparoscopic partial adrenalectomy in patients with adrenal tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
surgical outcomes
the postoperative function of the adrenal gland
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
laparoscopic partial adrenalectomy
Interventions/Control_2
laparoscopic total adrenalectomy(control)
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
Male and Female
Key inclusion criteria
intervention group
1. patinets who can understand this study and decide to join it
2. patinets whom we judge to be able to undergo laparoscopic partial adrenalectomy by the imaging and the adrenal venous sampling
control group
patients who underwent and will undergo laparoscopic total adrenalectomy in our hospital
Key exclusion criteria
intervention group
patients whom we judge to be unable to undergo laparoscopic partial adrenalectomy by the imaging and the adrenal venous sampling
control group
patients who decide not to joim this study
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Miyajima |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
akiram@a8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Morita |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
morishin75@a5.keio.jp
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Keio University School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 11 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 11 | 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
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 10 | Day |
Last modified on
| 2021 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017221
