UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013964
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

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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 or person

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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