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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019288
Receipt No. R000022301
Scientific Title Comparison of Renal Ischemic Damage During Laparoscopic Partial Nephrectomy With Artery-Vein and Artery-Only Clamping
Date of disclosure of the study information 2015/10/08
Last modified on 2015/10/08

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Basic information
Public title Comparison of Renal Ischemic Damage During Laparoscopic Partial Nephrectomy With Artery-Vein and Artery-Only Clamping
Acronym AV vs. AO clamp during laparoscopic partial nephrectomy
Scientific Title Comparison of Renal Ischemic Damage During Laparoscopic Partial Nephrectomy With Artery-Vein and Artery-Only Clamping
Scientific Title:Acronym AV vs. AO clamp during laparoscopic partial nephrectomy
Region
Japan

Condition
Condition renal tumor
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare renal ischemic damage caused by artery-only and artery-vein clamping after laparoscopic partial nephrectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes serum creatinine, eGFR, split renal function
Key secondary outcomes warm ischemic time, bleeding

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
100 years-old >
Gender Male and Female
Key inclusion criteria patients who undergo laparoscopic partial nephrectomy for renal mass
Key exclusion criteria patients with unilateral kidney
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhito Funahashi
Organization Nagoya University Graduate School of Medicine
Division name Urology
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya
TEL 052-744-2985
Email yfunahashi@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhito Funahashi
Organization Nagoya University Graduate School of Medicine
Division name Urology
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya
TEL 052-744-2985
Homepage URL
Email yfunahashi@med.nagoya-u.ac.jp

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

Funding Source
Organization Department of Urology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 08 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
Warm ischemic time was significantly shorter in the AV group than the AO group (26.3 vs. 30.7 min, respectively, p = 0.007). There were no differences in the estimated glomerular filtration rates or ERPF of the operated kidney between groups preoperatively or 1 week or 6 months postoperatively. The decrease in regional 99mTc-MAG3 uptake of the operated kidney at 1 week was correlated with warm ischemic time in both groups, being stronger in the AV group (p < 0.001) than in the AO group (p = 0.027). This decrease was significantly less in the AO group when the ischemic time was less than 25 min (88.1% vs 102.5%, p = 0.001).
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
2005 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 08 Month 01 Day
Last follow-up date
2013 Year 07 Month 31 Day
Date of closure to data entry
2013 Year 07 Month 31 Day
Date trial data considered complete
2013 Year 07 Month 31 Day
Date analysis concluded
2013 Year 08 Month 31 Day

Other
Other related information Warm ischemic time was significantly shorter in the AV group than the AO group (26.3 vs. 30.7 min, respectively, p = 0.007). There were no differences in the estimated glomerular filtration rates or ERPF of the operated kidney between groups preoperatively or 1 week or 6 months postoperatively. The decrease in regional 99mTc-MAG3 uptake of the operated kidney at 1 week was correlated with warm ischemic time in both groups, being stronger in the AV group (p < 0.001) than in the AO group (p = 0.027). This decrease was significantly less in the AO group when the ischemic time was less than 25 min (88.1% vs 102.5%, p = 0.001).

Management information
Registered date
2015 Year 10 Month 08 Day
Last modified on
2015 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022301

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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