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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011239
Receipt No. R000013170
Scientific Title Prospective trial of early ureteral ligation in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma
Date of disclosure of the study information 2013/07/21
Last modified on 2018/01/23

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Basic information
Public title Prospective trial of early ureteral ligation in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma
Acronym Prospective trial of early ureteral ligation in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma
Scientific Title Prospective trial of early ureteral ligation in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma
Scientific Title:Acronym Prospective trial of early ureteral ligation in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma
Region
Japan

Condition
Condition upper urinary tract urothelial carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Preventive effect of early ureteral ligation for bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bladder recurrence-free survival 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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Ureteral ligation before ligatiion of renal artery in nephroureterectomy for upper urinary tract urothelial carcinoma
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Upper urinary tract urothelial carcinoma
cM0
PS 0-2
No past history of bladder cancer or bladder tumor at the nephroureterectomy
Key exclusion criteria Multiple primary cancer
Target sample size 70

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shinichi Yamashita
Organization Tohoku University Graduate School of Medicine
Division name Urology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL 022-717-7278
Email yamashita@uro.med.tohoku.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shinichi Yamashita
Organization Tohoku University Graduate School of Medicine
Division name Urology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL 022-717-7278
Homepage URL
Email yamashita@uro.med.tohoku.ac.jp

Sponsor
Institute Department of Urology, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
2013 Year 07 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 09 Month 06 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 21 Day
Last modified on
2018 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013170

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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