UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017221