UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019288 |
|---|---|
| Receipt number | 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 21:29:51 |
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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
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
yfunahashi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Urology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022301
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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