Unique ID issued by UMIN | UMIN000013964 |
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Receipt number | R000016267 |
Scientific Title | Un-blinded Multicenter Study to Assess the Safety and Efficacy of Robotic-assisted (da Vinci surgical system, DVSS) Laparoscopic Partial Nephrectomy for Renal Cell Carcinoma Patients |
Date of disclosure of the study information | 2014/05/15 |
Last modified on | 2020/10/22 12:47:30 |
Un-blinded Multicenter Study to Assess the Safety and Efficacy of Robotic-assisted (da Vinci surgical system, DVSS) Laparoscopic Partial Nephrectomy for Renal Cell Carcinoma Patients
Un-blinded Multicenter Study of Robotic-assisted Laparoscopic Partial Nephrectomy
Un-blinded Multicenter Study to Assess the Safety and Efficacy of Robotic-assisted (da Vinci surgical system, DVSS) Laparoscopic Partial Nephrectomy for Renal Cell Carcinoma Patients
Un-blinded Multicenter Study of Robotic-assisted Laparoscopic Partial Nephrectomy
Japan |
cT1 Renal Canser
Urology |
Malignancy
NO
To assess the safety and efficacy of robotic-assisted (da Vinci surgical system, DVSS) laparoscopic partial nephrectomy for renal cell carcinoma patients.
As a historical control, the data of surgical and oncologic outcomes of laparoscopic partial nephrectomy: a Japanese multi-institutional study of 1375 patients, 54 sites is used.
Safety,Efficacy
Not applicable
Preservation of renal function and radical resection of renal cell carcinoma (negative surgical margin and ischemic time <25min.)
-Surgical time
-Console time
-Intraoperative blood loss
-Renal function (eGFR)
-Complete rate of the robotic-assisted laparoscopic partial nephrectomy
-Conversion to open surgery or laparoscopic surgery
-Postoperative recovery process (the date of first intraoral intake, postoperative hospital stay)
-Overall survival period
-Recurrence-free survival time
-Perioperative (during and early postoperative) adverse events (urine leakage, hemorrhage, etc.)
-Postoperative adverse events
-Late postoperative adverse events (cardiac, cerebrovascular diseases)
-Mechanical defects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
Laparoscopic partial nephrectomy using da Vinci surgical system (DVSS)
20 | years-old | <= |
Not applicable |
Male and Female
1)cT1 renal cell carcinoma clinically diagnosed by contrast enhanced CT abdomen scan (if the patient is unable to take the contrast agent, MRI will be performed), and a partial nephrectomy is able to be performed.
(slice of contrast enhanced CT abdomen must be <1 cm)
2)detecting no metastasis of lymph node or intra-abdominal organ by contrast enhanced CT abdomen scan (if the patient is unable to take the contrast agent, MRI will be performed) (cN0,cM0).
3)detecting no metastasis by the contrast enhanced CT chest scan or bone scintigraphy.
4)single tumor
5)
-WBC > 3000/microL
-Plt >= 10x10^4/microL
-AST =< 100 IU/L
-ALT =< 100 IU/L
-Total Bilirubin =< 2.0 mg/dL
-Serum creatinine =< 2.0 mg/dL
Tested within 6 weeks(42 days)prior to enrollment.
6)>= 20 years of age at the informed consent.
7)written informed consent is obtained.
1)multiple cancer
2)history of kidney transplantation.
3)therapies for renal cell cancer in the past 6 months.
4)unable to withdrawal of anticoagulation
5)anemia or hemorrhagic tendency requiring transfusion
6)obesity(Body Mass Index:BMI>=35)
7)dialysis patient.
8)pregnant, suspected of being pregnant, or lactating woman.
9)difficult to participate the study due to psychiatric disorder or psychological symptom.
10)inappropriate by the investigator or sub-investigator at the hospital (site) for any other reasons.
100
1st name | Masato |
Middle name | |
Last name | Fujisawa |
Kobe University Graduate School of Medicine
Division of Urology, Department of Surgery Related
6500017
7-5-2, Kusunokicho, Chuoku, Kobe, 650-0017, Japan
078-382-6155
uro6155@med.kobe-u.ac.jp
1st name | Kazushi |
Middle name | |
Last name | Tanaka |
Kobe University Graduate School of Medicine
Division of Urology, Department of Surgery Related
6500017
7-5-2, Kusunokicho, Chuoku, Kobe, 650-0017, Japan
078-382-6155
uro6155@med.kobe-u.ac.jp
Kobe University Graduate School of Medicine
Intuitive Surgical, Inc./CA, USA
Profit organization
Japanese society of endourology
kobe Univ. Hosp. Clinical and Translational Research
7-5-2, Kusunokicho, Chuoku, Kobe, Japan
078-382-5111
chiken@med.kobe-u.ac.jp
NO
神戸大学医学部附属病院(兵庫県) Kobe University Hospital(Hyogo pref.)
鳥取大学医学部附属病院(鳥取県)Tottori University Hospital (Tottori pref.)
岡山大学病院(岡山県) Okayama University Hospital (Okayama pref.)
名古屋大学医学部附属病院(愛知県) Nagoya University Hospital (Aichi pref.)
藤田医科大学病院(愛知県) Fujita Health University Hospital (Aichi pref.)
徳島大学病院(徳島県) Tokushima University Hospital (Tokushima pref.)
広島大学病院(広島県) Hiroshima University Hospital (Hiroshima pref.)
九州大学病院(福岡県) Kyushu University Hospital (Fukuoka pref.)
東北大学病院(宮城県) Tohoku University Hospital (Miyagi pref.)
聖路加国際病院(東京都) St. Luke’s International Hospital (Tokyo)
名古屋市立大学病院(愛知県)/Nagoya City University Hospital(Aichi pref.)
順天堂大学医学部附属順天堂医院(東京都)/Juntendo University Hospital(Tokyo)
秋田大学医学部附属病院(秋田県)/Akita University Hospital(Akita pref.)
弘前大学医学部附属病院(青森県)/Hirosaki University School of Medicine & Hospital(Aomori pref.)
2014 | Year | 05 | Month | 15 | Day |
Partially published
118
The achievement rate of the primary endpoint was 91.3% (95%CI:84.1-95.9%). It was significantly higher than the preset threshold (23.3%).
2020 | Year | 10 | Month | 22 | Day |
2018 | Year | 01 | Month | 31 | Day |
Completed
2014 | Year | 01 | Month | 27 | Day |
2014 | Year | 01 | Month | 27 | Day |
2014 | Year | 09 | Month | 10 | Day |
2020 | Year | 01 | Month | 28 | Day |
2020 | Year | 04 | Month | 06 | Day |
2020 | Year | 04 | Month | 20 | Day |
2020 | Year | 07 | Month | 03 | Day |
2014 | Year | 05 | Month | 15 | Day |
2020 | Year | 10 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016267
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