Unique ID issued by UMIN | UMIN000026384 |
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Receipt number | R000030318 |
Scientific Title | Clinical study on sentinel pelvic lymphnode analysis with Indocyanine Green (ICG) navigation for prostate cancer and bladder cancer using da Vinci Xi system |
Date of disclosure of the study information | 2017/05/01 |
Last modified on | 2020/03/04 18:33:34 |
Clinical study on sentinel pelvic lymphnode analysis with Indocyanine Green (ICG) navigation for prostate cancer and bladder cancer using da Vinci Xi system
Xi-ICG pelvic sentinel node study
Clinical study on sentinel pelvic lymphnode analysis with Indocyanine Green (ICG) navigation for prostate cancer and bladder cancer using da Vinci Xi system
Xi-ICG pelvic sentinel node study
Japan |
prostate cancer, bladder cancer
Urology |
Malignancy
NO
We will sutdy the possibility of the appropriate lymph node dissection for prostate cancer and bladder cancer by using indocyanine green.
Safety,Efficacy
Exploratory
Lynmph flow pattern ratio, the accuracy rate of sentinel lymph nodes
Comparison between conventional lymph node templates and sentinel lymph nodes, safty of indocyanine green administration
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Diagnosis
Medicine |
After injecting ICG into the prostate gland, observe with a near infrared camera on the da Vinci Xi system and classify lymph flow. The ICG positive site within the template dissection area is dissected and additionally dissected out of the ICG positive site outside the template dissection supernatant is performed.
35 | years-old | <= |
85 | years-old | >= |
Male and Female
1) For the cases of the robotic radical prostatectomy or cystectomy using da Vinci Xi system with clinical stage T1-T3N0-M0
2) 35 years old and over, under 85
3) ECOG performance status score: 0 and 1
4) Preserving the major organ functions for geneneral anesthesia by general condition workup within the prior 3months
5) With written consent forms by the patients themselves
1)Excluded those with allergic history of ICG
2)The cases with inappropriate for this study made by the persons in charge
100
1st name | Masaki |
Middle name | |
Last name | Shimbo |
St.Luke's International Hospital
Department of Urology
1048560
9-1, Akashi-cho, Chuo-ku, Tokyo, Japan
03-3541-5151
mashimbo@luke.ac.jp
1st name | Masaki |
Middle name | |
Last name | Shimbo |
St.Luke's International Hospital
Department of Urology
1048560
9-1, Akashi-cho, Chuo-ku, Tokyo, Japan
03-3541-5151
mashimbo@luke.ac.jp
Department of Urology, St. Luke's International Hospital
Department of Urology, St. Luke's International Hospital
Other
St.Luke's International hospital
9-1, Akashi-cho, Chuo-ku, Tokyo
0335415151
kenkyukikaku@luke.ac.jp
NO
2017 | Year | 05 | Month | 01 | Day |
Unpublished
Completed
2017 | Year | 03 | Month | 01 | Day |
2017 | Year | 06 | Month | 08 | Day |
2017 | Year | 04 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2017 | Year | 03 | Month | 03 | Day |
2020 | Year | 03 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030318
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