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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014813
Receipt No. 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 2014/08/10

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Last 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
Email akiram@a8.keio.jp

Public contact
1st 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
Email morishin75@a5.keio.jp

Sponsor
Institute Department of Urology, Keio University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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 Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 10 Day
Last modified on
2014 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017221


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