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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013964
Receipt No. 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

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Basic information
Public 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
Acronym Un-blinded Multicenter Study of Robotic-assisted Laparoscopic Partial Nephrectomy
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
Scientific Title:Acronym Un-blinded Multicenter Study of Robotic-assisted Laparoscopic Partial Nephrectomy
Region
Japan

Condition
Condition cT1 Renal Canser
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Preservation of renal function and radical resection of renal cell carcinoma (negative surgical margin and ischemic time <25min.)
Key secondary outcomes -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

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
Device,equipment
Interventions/Control_1 Laparoscopic partial nephrectomy using da Vinci surgical system (DVSS)
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

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Fujisawa
Organization Kobe University Graduate School of Medicine
Division name Division of Urology, Department of Surgery Related
Zip code 6500017
Address 7-5-2, Kusunokicho, Chuoku, Kobe, 650-0017, Japan
TEL 078-382-6155
Email uro6155@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Kazushi
Middle name
Last name Tanaka
Organization Kobe University Graduate School of Medicine
Division name Division of Urology, Department of Surgery Related
Zip code 6500017
Address 7-5-2, Kusunokicho, Chuoku, Kobe, 650-0017, Japan
TEL 078-382-6155
Homepage URL
Email uro6155@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Intuitive Surgical, Inc./CA, USA
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Japanese society of endourology
Name of secondary funder(s)

IRB Contact (For public release)
Organization kobe Univ. Hosp. Clinical and Translational Research
Address 7-5-2, Kusunokicho, Chuoku, Kobe, Japan
Tel 078-382-5111
Email chiken@med.kobe-u.ac.jp

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 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.)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 118
Results
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%).
Results date posted
2020 Year 10 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 01 Month 31 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 01 Month 27 Day
Date of IRB
2014 Year 01 Month 27 Day
Anticipated trial start date
2014 Year 09 Month 10 Day
Last follow-up date
2020 Year 01 Month 28 Day
Date of closure to data entry
2020 Year 04 Month 06 Day
Date trial data considered complete
2020 Year 04 Month 20 Day
Date analysis concluded
2020 Year 07 Month 03 Day

Other
Other related information

Management information
Registered date
2014 Year 05 Month 15 Day
Last modified on
2020 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016267

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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