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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003053
Receipt No. R000003674
Scientific Title Laparoscopic retroperitoneal lymph node dissection for genitourinary cancer
Date of disclosure of the study information 2010/01/18
Last modified on 2012/11/07

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Basic information
Public title Laparoscopic retroperitoneal lymph node dissection for genitourinary cancer
Acronym Laparoscopic retroperitoneal lymph node dissection for genitourinary cancer
Scientific Title Laparoscopic retroperitoneal lymph node dissection for genitourinary cancer
Scientific Title:Acronym Laparoscopic retroperitoneal lymph node dissection for genitourinary cancer
Region
Japan

Condition
Condition testicular tumor, renal cell carcinoma, urothelial cancer, prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The investigation of safety of laparoscopic retroperitoneal lymph node dissection
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes complication, time to first walk, time to first oral intake, length of hospital stay, overall survival, recurrence-free rate,
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria retroperitoneal lymph node metastasis of testicular tumor after chemoterapy or radiation therapy
testicular tumor StageI
retroperitoneal lymph node reccurence of RCC or urothelial cancer after radical therapy
localized prostate cancer
Key exclusion criteria serious mental disease
unrecovered myelosuppression
hemorrhagic diathesis
uncontroled diabetes mellitus
serious infectious disease
inadequate case in physician's opinion
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Eto
Organization Kumamoto University Hospital
Division name Urology
Zip code
Address Honjo 1-1-1, Kumamoto, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kumamoto University Hospital
Division name Urology
Zip code
Address
TEL
Homepage URL
Email tkhshwtr@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University Hospital
Institute
Department

Funding Source
Organization Kumamoto University 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
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
2010 Year 01 Month 18 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
2009 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 18 Day
Last modified on
2012 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003674

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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