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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name